Type 2 DiabetesON LiMiTNCT07262788
A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes
A study testing CH-rich diet with exercise and CH-reduced diet with exercise in people with Type 2 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
The overall aim of this study is to examine the feasibility of a 12-month, two-arm lifestyle intervention to induce and maintain remission of type 2 diabetes (T2D). The findings from the feasibility study will inform the recruitment, design and delivery of the interventions in a 5-arm, 24-month randomised controlled… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- CH-rich diet with exercise and CH-reduced diet with exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Sep 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of T2D. Treatment lifestyle changes, oral anti-diabetic medication including metformin, and/or sulfonylureas and/or DPP-4 inhibitors and/or SGLT2 inhibitors and/or incretin-based medication
- HbA1c between 36-86 mmol/mol
- T2D duration of ≤6 years
- BMI ≥27 kg/m2
- Body weight changes over 3 months ≤3 kg
Who cannot join
- Insulin treatment within 6 months prior to screening (any type)
- Heart failure (ejection fraction ≤40%) and treated with SGLT-2i (current or planned)
- Cardiovascular disease, including previous heart attack or stroke, for which incretin-based therapy and/or an SGLT-2i has been prescribed.
- Kidney disease (eGFR <60 ml/min/1,73m² and/or albuminuria (≥30 mg/g) for at least three months) and treated with SGLT-2i (current or planned)
- Physical comorbidity, which precludes the physical activity during intervention
- Dietary restrictions or allergies making the participant unable to adhere to the dietary interventions
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- Unable to comply with trial procedures and/or interventions
- Alcohol/drug abuse
- Planned or present pregnancy/fertility treatment, or lack of contraception during reproductive age
- Unstable psychiatric disease that is deemed to impede participation in the project
- Diagnosed with binge eating disorder
- Participation (present or planned) in other clinical trials including lifestyle or pharmacy trials for any condition
- If HbA1c ≥60 mmol/mol and the participant is on 2 or more anti-diabetic drugs and has a positive GAD65 and/or stimulated C-peptide <800 pM
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jonas Salling Quist Senior Researcher and Associate Professor, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Steno Diabetes Center Copenhagen
Herlev, Denmark, 2730
Jonas Salling Quist Associate Professor, PhD, +45 26176064, jonas.salling.quist@regionh.dk
About this study
Official title: A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes (ON LiMiT)
The overall aim of this study is to examine the feasibility of a 12-month, two-arm lifestyle intervention to induce and maintain remission of type 2 diabetes (T2D). The findings from the feasibility study will inform the recruitment, design and delivery of the interventions in a 5-arm, 24-month randomised controlled trial.
Read the detailed description
Studies on T2D remission have reported varying rates of remission, often around 50% in intervention groups. These studies typically involve individuals with a recent T2D diagnosis, usually within six to ten years of diagnosis, with intervention periods most commonly lasting between twelve and twenty-four months, though durations have ranged from six to sixty months. Lifestyle interventions combining dietary changes and increased physical activity generally yield modest remission rates, but maintaining adherence over time remains challenging. Trials that include an initial phase of a very low-calorie diet, followed by ongoing structured support, tend to report higher remission rates. This emphasizes the critical role of significant and sustained weight loss. However, the most effective combination of dietary, exercise, and behavioral support strategies remains to be determined.
In addition to calorie restriction, changes in dietary composition may influence the underlying mechanisms of T2D. For instance, reducing carbohydrate intake can promote ketone production, affecting liver glucose production and improving glycemic control. Higher protein intake has been linked to an improved insulin response. Replacing saturated fats with polyunsaturated fats and increasing dietary fiber may also support glucose metabolism. However, it remains unclear whether carbohydrate-reduced or carbohydrate-rich diets are more effective in supporting long-term remission following initial weight loss.
Physical activity, particularly high-intensity exercise, plays a key role in reducing the risk of T2D, supporting weight management, and improving remission rates when combined with dietary interventions. Significant improvements in blood glucose control are usually seen with regular moderate-to-high-intensity exercise.
Moreover, there is considerable variation-or sometimes an absence-in the inclusion of key lifestyle intervention components, such as specific dietary and exercise protocols, as well as levels of supportive activities. This inconsistency complicates effective care provision for healthcare professionals and makes it difficult for individuals with T2D to adhere to non-pharmacological management recommendations.
Despite the known benefits of lifestyle modifications, initiating and maintaining these changes is challenging due to barriers such as a lack of support, motivation, and knowledge about nutrition and portion sizes. Involving individuals with T2D in designing and evaluating interventions may improve adherence, reduce participant burden, and increase the feasibility and scalability of lifestyle programs for wider implementation.
The overall aim of this study is to examine the feasibility of a 12-month, two-arm intervention designed to induce and maintain remission of T2D. After baseline measurements, participants will be randomized to one of two groups: Group A: Very-low-calorie-diet (VLCD)/weight loss followed by a carbohydrate-reduced (CH-reduced) diet combined with high-intensity exercise. Group B: VLCD/weight loss followed by a carbohydrate-rich (CH-rich) diet combined with high-intensity exercise. Participants and study staff will be blinded to the intervention arm during the VLCD phase.
To determine the optimal macronutrient composition of the Mixed Meal Tolerance Test (MMTT) for subsequent testing, participants will undergo three different MMTTs consisting of 550 kcal in random order at baseline; a low-carbohydrate meal (27/30/43 energy percentage (E%) from carbohydrate/protein/fat), an intermediate-carbohydrate meal (40/23/37 E%), and a high-carbohydrate meal (53/17/30 E%). Postprandial responses to the intermediate-carbohydrate meal will be evaluated against those to the low- and high-carbohydrate meal in terms of glucose, insulin, C-peptide, free fatty acids, and triglycerides during 240 minutes. If the responses are deemed sufficiently favorable, the intermediate-carbohydrate meal will be selected for MMTTs conducted at weeks 12, 18, and 52.
Feasibility will be evaluated based on the recruitment process, intervention acceptability, and participant adherence. This includes assessing whether the intervention components and outcome measurements are delivered and conducted as intended. Additionally, the study will examine how these elements perform in a real-life setting among individuals with T2D. Findings from this feasibility study will inform recruitment strategies, study design, and implementation of a subsequent five-arm, 24-month randomized controlled trial.
Specific aims:
- To study the recruitment process (including recruitment of general practitioners and participants) and identify related barriers and facilitators.
- To investigate retention, adherence, and acceptability of the interventions (carbohydrate-reduced or carbohydrate-rich diet combined with high-intensity exercise), including participant experiences with the intervention components and data collection procedures.
- To assess whether the intervention is delivered as intended, covering supervised/unsupervised sessions, study visits, online support, and group education.
- To evaluate the effectiveness of safety procedures in responding to changes in participants' glycemic control, blood pressure, physical injuries, and related risk markers.
- To determine the optimal macronutrient composition and sampling schedule for the Mixed Meal Tolerance Test (MMTT).
- To explore the potential impact of the two interventions on T2D remission rates and related metabolic outcomes such as body weight, body composition, blood pressure, vascular function, glycemic control, lipid profile, beta-cell function, and inflammation.
- Conditions
- Type 2 Diabetes
- Being tested
- CH-rich diet with exercise, CH-reduced diet with exercise
- Keywords
- Type 2 Diabetes, Obesity, Remission, Feasibility, Diet, Overweight, Lifestyle Intervention, Exercise
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CH-rich diet with exerciseOther
After 12 weeks of following a VLCD (Phase 1), participants begin a 6-week transition (Phase 2). During this phase, they adopt a CH-rich diet, consuming 50-55% of their total energy from carbohydrates. This involves shifting gradually but structurally from formula products to regular meals. Meal boxes and formula products aligned with their assigned diet support this shift and serve as educational tools. Phase 2 also includes an exercise program consisting of two supervised 1-hour sessions and one 1-hour unsupervised high-intensity session weekly (intensity >70% peak oxygen uptake (VO2peak) and/or >7 on the Rate of Perceived Exertion scale (RPE), equivalent to 1-3 repetitions in reserve for resistance training or vigorous intensity). For the next 34 weeks (Phase 3), participants receive ongoing diet and exercise support while purchasing and preparing their own meals according to their assigned diet. They continue with two supervised and one unsupervised group session per week.
CH-reduced diet with exerciseOther
After 12 weeks of following a VLCD (Phase1), participants begin a six-week transition (Phase 2 ). During this phase, they adopt a CH-reduced diet, consuming 25-30% of their total energy from carbohydrates. This involves shifting gradually but structurally from formula products to regular meals. Meal boxes and formula products aligned with their assigned diet support this shift and serve as educational tools. Phase 2 also includes an exercise program consisting of two supervised 1-hour sessions and one 1-hour unsupervised high-intensity session weekly (intensity >70% peak oxygen uptake (VO2peak) and/or >7 on the RPE scale, equivalent to 1-3 repetitions in reserve for resistance training or vigorous intensity). For the next 34 weeks (Phase 3), participants receive ongoing diet and exercise support while purchasing and preparing their own meals according to their assigned diet. They continue with two supervised and one unsupervised group session peer week.
| Study group | Role | What they receive |
|---|---|---|
| CH-rich diet with exercise | Experimental | A CH-rich diet combined with an exercise programme (n=12) Receives: Other: CH-rich diet with exercise |
| CH-reduced diet with exercise | Experimental | A CH-redcued diet combined with an exercise programme (n=12) Receives: Other: CH-reduced diet with exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility testing of diet adherence
Derived from myfood24 dietary recalls collected over three consecutive days at pre-specified time points. A recall day is adherent if E% carbohydrate is within the arm-specific target ±10 E%. Participant-level percent compliance at each time point is calculated as (adherent recall days / valid recall days) × 100.
Measured: Baseline, weeks 18, 24, 36, and 52.
Feasibility testing of exercise adherence
Adherence is assessed based on self-report and measured (wearable heart rate monitor) using study app and calculated as number of completed sessions / total prescribed sessions.
Measured: 3 sessions pr. week, from week 13 to 52.
Feasibility testing of GP recruitment & safety procedures - quantitative assessment
The recruitment of GPs will be assessed based on the number who express interest, attend instruction and sign collaboration agreements. The reasons for GP non-participation or withdrawal will be documented and, if possible, the GPs will be interviewed. Contacts with GPs that are safety-related, and their responses, including the outcomes of medication changes, will be recorded.
Measured: Through study completion, an average of 52 weeks.
Feasibility testing of GP experiences and study procedures - qualitative assessment
Interviews with one GP or staff member from each participating clinic will explore experiences with study procedures, including barriers and opportunities related to recruitment and medication discontinuation, as well as any unintended consequences.
Measured: Through study completion, an average of 52 weeks.
Feasibility testing of participant recruitment & retention
Registered numbers of: individuals expressing interest in the project, participants completing pre-screening (telephone interview) and in-person screening, participants included in the study, drop-outs and completers. Reasons for exclusion or withdrawal will be documented.
Measured: Through study completion, an average of 52 weeks.
Feasibility testing of intervention participation - quantitative assessment
The degree of implementation of intervention activities and the extent of participant engagement will be measured by tracking attendance and completion of planned intervention components, including intervention visits, supervised and unsupervised exercise sessions, phone calls, at-home measurements, group-based education sessions, and peer support activities. Data will be collected via REDCap (8.10.18, Vanderbilt University, TN, USA) and study logs to quantify the proportion of completed versus scheduled activities for each participant.
Measured: Through study completion, an average of 52 weeks.
Feasibility testing of intervention participation - qualitative assessment
Group-based diet and exercise sessions will be observed to assess how the intervention is delivered in practice and how participants engage with the activities. Field notes will document group dynamics, adherence to session protocols, and contextual factors. Field notes will also inform interview guides and supplement interview data.
Measured: Through study completion, an average of 52 weeks.
Feasibility testing of protocol adherence - number of days with deviations
Total number of days during which participants did not adhere to the planned intervention protocol or experienced protocol deviations during the three intervention phases.
Measured: Through study completion, an average of 52 weeks.
Feasibility testing of acceptability and experiences
Interviews with participants, dieticians and exercise instructors.
Measured: Through study completion, an average of 52 weeks plus a 3-month follow-up interview with participants.
Secondary outcomes (83)
Evaluation of dietary screener to assess adherence
A dietary screener will be used to generate a binary off-track flag to enable timely dietitian outreach when participants may need support to improve adherence during the study period. As part of the dietary screener, participants will complete an overall self-assessment of adherence to their allocated diet during the past 7 days. Participant ratings will be compared with the dietitian's adherence rating following flagged checks, and interrater agreement (participant vs. dietitian) and agreement with MyFood24-derived adherence will be explored.
Measured: Every 2 weeks from week 15 to week 52.
Dietary intake
Dietary intake, including energy intake (kcal/day) and macronutrient intake (total in grams and E% per day) and micronutrient intake (units/day) based on 3-days' dietary recalls based on MyFood24.
Measured: Measured at baseline, weeks 18, 24, 36, and 52.
Diabetes remission
Number of participants with HbA1c < 48 mmol/mol maintained for at least 3 months without glucose-lowering medication.
Measured: Measured at weeks 12, 18, 30, 42, and 52.
Body weight (kg)
Measured to nearest 0.1 kg using a digital scale. Fasted state.
Measured: Changes from baseline to the end of the intervention measured at four time points (baseline, weeks 12, 18, and 52).
Achieved clinically relevant weight loss (≥10%)
Number of participants who achieved a weight loss of at least 10% of their baseline body weight. Measured to nearest 0.1 kg using a digital scale. Fasted state.
Measured: Measured at baseline, weeks 12, 18, and 52.
HbA1c (mmol/mol and %)
Assessed from blood samples collected in non-fasting state.
Measured: Measured at screening, baseline, weeks 12, 18, 30, 42, and 52.
GAD65 Antibodies (U/mL)
Assessed from blood samples collected in non-fasting state.
Measured: Measured at screening.
Marker of kidney function - eGFR (mL/min)
Estimated glomerular filtration rate (eGFR).
Measured: Measured at baseline, weeks 12, 18, and 52.
Marker of kidney function - Creatinine (μmol/L)
Concentration of creatinine, assessed from blood sample in fasting state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Marker of kidney function - Potassium (mmol/L)
Concentration of potassium, assessed from blood sample in fasting state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Marker of kidney function - Sodium (mmol/L)
Concentration of sodium, assessed from blood sample in fasting state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Plasma Albumin (g/L)
Fasting concentration of plasma albumin.
Measured: Measured at baseline, weeks 12, 18, and 52.
Plasma Hemoglobin (g/L)
Fasting concentration of plasma hemoglobin.
Measured: Measured at baseline, weeks 12, 18, and 52.
White Blood Cells (10⁹/L)
Fasting concentration of white blood cells.
Measured: Measured at baseline, weeks 12, 18, and 52.
Height (m)
Measured using a using an ultrasonic device to nearest 0.1 cm in order to calculate BMI.
Measured: Measured at baseline.
Body weight (kg)
Measured to nearest 0.1 kg, in the morning, after urinating, before ad libitum diet acc to ad libitum intake of allocated intervention diet, using wireless scales at participants' home.
Measured: Time frame: Collected once weekly from week 1 to 52.
Body mass index (kg/m^2)
Calculated from body weight (kg) and height (m). Fasted state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Gut Microbiome Composition
Fecal samples will be analyzed for microbiome composition and diversity using 16S rRNA gene sequencing and shotgun metagenomic sequencing.
Measured: Collected at baseline, weeks 12, 18, and 52.
Urine spot samples for dietary biomarkers (home collection)
Participants will collect three consecutive morning midstream urine samples and four additional spot urine samples at home. Urine samples will be analyzed by metabolomic profiling to quantify urinary concentrations of at least 10 dietary biomarkers, including Sulforaphane-N-acetylcysteine (broccoli), Proline betaine (citrus fruits), Carnosine (meat), and 3,5-dihydroxybenzoic acid glucuronides (whole grains).
Measured: Collected at weeks 18, 24, 36, 42, and 52
Urine Albumin-to-Creatinine Ratio (at site)
Urine spot samples will be collected to assess renal function and diabetes-related kidney involvement.
Measured: Measured at baseline, weeks 12, 18, and 52.
Saliva microbiome composition
Saliva samples, analyzed for microbial composition changes via 16S rRNA and metagenomic.
Measured: Collected at baseline, weeks 12, 18, and 52.
Metabolites - Mixed Meal Tolerance Test
Concentrations of metabolites including, but not limited to, glucose, triglycerides, free fatty acids (FFA), and alanine will be assessed during the MMTT at 8 time points; before the meal while fasting (minutes -15 and -5) and postprandially (minutes 30, 60, 90, 120, 180, and 240). Additionally, concentrations of lipoproteins and intact and split proinsulin will be measured in the fasting samples.
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Glucometabolic and gut hormones (pmol/L and pmol/L*min) - Mixed Meal Tolerance Test
Optionally, concentrations of hormones involved in glucose and lipid metabolism and appetite regulation including insulin, glucagon, C-peptide, GLP-1, GIP, ghrelin, PYY, CCK and more variables will be assessed during the MMTT at 8 time points; before the meal while fasting (minutes -15 and -5) and postprandially (minutes 30, 60, 90, 120, 180, and 240). Results will be expressed in pmol/L. Area under the curve (AUC) will be expressed as pmol/L*min.
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Insulin Sensitivity - Mixed Meal Tolerance Test
Insulin sensitivity will be estimated from postprandial responses of relevant metabolites obtained during the MMTT using validated model-based indices.
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
β-Cell Function - Mixed Meal Tolerance Test
β-cell function will be estimated from postprandial responses of relevant metabolites obtained during the MMTT using validated model-based indices.
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Hepatic First-Pass Insulin Extraction - Mixed Meal Tolerance Test
Hepatic first-pass insulin extraction will be estimated from postprandial responses of relevant metabolites obtained during the MMTT using validated model-based indices.
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Metabolic Insulin Clearance - Mixed Meal Tolerance Test
Metabolic insulin clearance will be estimated from postprandial responses of relevant metabolites obtained during the MMTT using validated model-based indices.
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Subjective appetite sensations - Mixed Meal Tolerance Test
Rated using visual analogue scales (VAS) and includes sensations of: Hunger, fullness, satiety, prospective food consumption, wellbeing, nausea, thirst, desire to eat meat, salty, or sweet. The scale range is 0-100 and each end represent the extremes e.g. hunger rating: "I am not hungry at all" to "I have never been this hungry before". VAS ratings are collected at 7 time points during the MMTT; before the meal while fasting (minute -10) and postprandially (minutes 30, 60, 90, 120, 180, 240).
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Physical activity
Physical activity (PA) including but limited to: PA (time spent at different intensities (sedentary activity, low light activity, high light activity, moderate to vigorous activity, vigorous activity), PA (total counts, counts/min), PA energy expenditure (kcal/day), PA (MET hours) and timing of PA (hh:mm) will be objectively assessed using a thigh-mounted accelerometer (SENS Motion). Participants will wear the device 24 hours/day for 10 consecutive days prior to visits. Data will provide time-stamped estimates of sedentary time, time spent standing, walking, bicycling, and intensity of movement.
Measured: Measured at baseline, weeks 12, 18, and 52.
Waist circumference (cm)
Measured using tape measure to the nearest 0.5 cm. Fasted state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Hip circumference (cm)
Measured using tape measure to the nearest 0.5 cm. Fasted state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Waist/hip ratio
The ratio of the circumference of the waist to that of the hips.
Measured: Measured at baseline, weeks 12, 18, and 52.
Fat mass (kg)
Measured by Dual-energy X-ray Absorptiometry in a fasted state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Fat free mass (kg)
Measured by Dual-energy X-ray Absorptiometry in a fasted state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Fat percentage (%)
Measured by Dual-energy X-ray Absorptiometry in a fasted state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Bone mass (kg)
Measured by Dual-energy X-ray Absorptiometry in a fasted state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Marker of liver function - Degree of liver fibrosis (kPa)
Measured by FibroScan in a fasted state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Marker of liver function - Degree of liver steatosis (dB/m)
Measured by FibroScan in a fasted state.
Measured: Measured at baseline, weeks 12, 18, and 52.
Marker of liver function - FIB-4 Index
Will be calculated from participants' age and fasting concentration of aspartate-aminotransferase (U/L), alanine-aminotransferase (U/L) and thrombocytes (x10^9/L).
Measured: Measured at baseline, weeks 12, 18, and 52.
Cognition
Cognitive functions will be assessed by Screen for Cognitive Impairment in Psychiatry Danish Version (SCIP-D) together with the Trail Making Test Part B (TMT-B, psychomotor speed and executive function).
Measured: Measured at baseline, weeks 12, and 52.
Food choice - Food preferences and food reward
Food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Food choice is determined based on frequency of selection made within each food category. The scores range from 0-48 i.e. 0 = foods within a specific food category have not been selected at all to 48 = foods within a specific food category have been selected 48 times.
Measured: Measured at baseline, weeks 12, 18, and 52.
Food attention - Food preferences and food reward
Measured using eye tracking in response to looking at food pictures during Steno Biometric Food Preference Task (SBFPT). Includes the following parameters: Gaze: Time spent (ms and %) and visits (n); and fixations: Time to first fixation (ms), time spent (ms and %), fixation count (n), first fixation duration (ms), average fixation duration (ms). Distance to screen (mm), and gaze direction bias (ratio) which is calculated as the number of trials in which the first fixation was directed to a food image as a proportion to all trials. A bias score >0.5 indicates attention towards one food image, a bias score equal to 0.5 indicates no bias, and a bias score <0.5 indicates attention towards the other food images.
Measured: Measured at baseline, weeks 12, 18, and 52.
Food reaction time (ms) - Food preferences and food reward
Reaction time during forced food choice of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fatsavoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT).
Measured: Measured at baseline, weeks 12, 18, and 52.
Explicit liking - Food preferences and food reward
Explicit liking of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savouryand low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Explicit liking is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how pleasant would it be to taste this foodright now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Measured: Measured at baseline, weeks 12, 18, and 52.
Implicit wanting - Food preferences and food reward
Implicit wanting of food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Implicit wanting is assessed based on food choice and response time for selected and non-selected food items as well as mean response time (a frequency-weighted algorithm). In this frequency-weighted algorithm a positive score indicates a morerapid preference for a food type over another food type and a negative score indicates the opposite. A score of zero indicates that food types are equally preferred. The frequency weighted algorithm isused so the implicit wanting score is influenced by both selection (positively contributing to the score) and non-selection (negatively contributing to the score) of food type. Scores for implicit wanting typically range from -100-100 (due to reaction time there is no fixedmin-max value).
Measured: Measured at baseline, weeks 12, 18, and 52.
Explicit wanting - Food preferences and food reward
Explicit wanting of 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT). Explicit wanting is rated using visual analogue scales and the range is 0-100. Each end represents the extremes e.g. Question: "how much do you want some of this food now?" Answer: "not at all" (rated 0 on the 0-100 scale) to "extremely" (rated 100 on the 0-100 scale).
Measured: Measured at baseline, weeks 12, 18, and 52.
Unspecified exploratory outcome - Food preferences and food reward
Unspecified exploratory outcomes related to the 16 food items from four combined food categories (high-fat savoury, high-fat sweet, low-fat savoury and low-fat sweet foods) examined from the Steno Biometric Food Preference Task (SBFPT).
Measured: Measured at baseline, weeks 12, 18, and 52.
Systolic blood pressure (mmHg)
Measured under resting and fasting conditions.
Measured: Measured at baseline, weeks 12, 18, and 52.
Diastolic blood pressure (mmHg)
Measured under resting and fasting conditions.
Measured: Measured at baseline, weeks 12, 18, and 52.
Resting heart rate (bpm)
Measured under resting and fasting conditions.
Measured: Measured at baseline, weeks 12, 18, and 52.
Cardiac rhythm (ECG)
A standard 12-lead resting ECG will be performed to assess cardiac rhythm and detect potential contraindications for maximal exercise testing. This screening is conducted to ensure participant safety prior to performing the VO₂ peak test.
Measured: Measured at baseline.
Peak oxygen uptake (ml O2/min)
Peak oxygen consumption (VO2peak) as a measure of cardiorespiratory fitness will be measured by an incremental bicycle ergometer test.
Measured: Measured at baseline, weeks 12, 18, and 52.
Cardiorespiratory fitness (ml O2/min/kg)
Peak oxygen consumption (VO2peak) per kg body weight as a measure of cardiorespiratory fitness. Measured by an incremental bicycle ergometer test.
Measured: Measured at baseline, weeks 12, 18, and 52.
Time-in-range (% 3.9-10.0 mmol/L)
Measured using a blinded continuous glucose monitoring device (CGM). The sensor will be placed subcutaneously on the upper arm or abdomen, and worn for 10-14 days prior to visits.
Measured: Measured at baseline, weeks 1 and 51.
Time-below-range (% <3.9 mmol/L)
Measured using a blinded continuous glucose monitoring device (CGM). The sensor will be placed subcutaneously on the upper arm or abdomen, and worn for 10-14 days prior to visits.
Measured: Measured at baseline, weeks 1 and 51.
Time-above-range (% >10.0 mmol/L)
Measured using a blinded continuous glucose monitoring device (CGM). The sensor will be placed subcutaneously on the upper arm or abdomen, and worn for 10-14 days prior to visits.
Measured: Measured at baseline, weeks 1 and 51.
Coefficient of variation (CV) of glucose concentrations
Measured using a blinded continuous glucose monitoring device (CGM). The sensor will be placed subcutaneously on the upper arm or abdomen, and worn for 10-14 days prior to visits.
Measured: Measured at baseline, weeks 1 and 51.
Heart rate (bpm)
Assessed from GPS-based smart watch.
Measured: Measured from weeks 16 to 51 during exercise sessions.
Self-reported quality of life
Assessed using the Quality of Life (12-Item Short Form Survey, SF-12), which measures health-related quality of life across physical and mental health domains. The questionnaire includes 12 items and yields two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Scores range from 0 to 100, with higher scores indicating better health status. A PCS score of 50 or below may indicate physical health impairment, while an MCS score of 42 or below may suggest clinical depression.
Measured: Measured at baseline, weeks 12 and 52.
Self-reported health-related quality of life
Assessed from the questionnaire European Quality of Life - 5 Dimensions (EQ-5D). EQ-5D comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on 3 or 5 levels of severity. A health utility index score is derived, ranging from values below 0 (where 0 represents death and negative values represent states worse than death) to 1 (full health). Higher scores indicate better health-related quality of life.
Measured: Measured at baseline, weeks 12 and 52.
Changes in sum score of The 25-item Bodily Distress Syndromes (BDS) checklist
Measure of severity of symptom burden. The number of non-missing (answered) items in the 25-item Bodily Distress Syndromes (BDS) checklist (from bds1 to bds25) is counted for each individual to determine if enough data is available to compute a score. Then, if at least 13 items are answered, the average of the available responses is calculated, scaled to a 0-100 range, rounded to the nearest whole number, and saved as the BDS sum score. Lower value is better.
Measured: Measured at baseline, weeks 12 and 52.
Changes in symptom cases
For each of the following domains: cardiopulmonary symptoms (b1-b6), gastrointestinal symptoms (b7-b13), musculoskeletal symptoms (b14-b20) and general symptoms (b21-b25).Bimodal variable for cases - Number of symptoms scored above 1 (including Somewhat, Quite a bit \& A lot). Participants reporting ≥4 such symptoms and with fewer than 3 missing responses will be classified as a case being at least four symptoms within each domain (binary variable: 1 = case, 0 = non-case).
Measured: Measured at baseline, weeks 12 and 52.
Self-reported diabetes distress
Assessed from the Problem Areas in Diabetes Scale (PAID-5 scale) comprising five of the emotional-distress questions of the full PAID items. Each item can be rated from 0 to 4. A total score of ≥8 indicates possible diabetes related emotional distress.
Measured: Measured at baseline, weeks 12 and 52.
Self-reported loneliness
Assessed from the questionnaire The Three Item Loneliness Scale (TILS). TILS consists of 3 items assessing subjective feelings of loneliness and social isolation. Scores range from 3 to 9, with higher scores indicating greater loneliness. A score of 6 or above has been used as a cut-off to indicate elevated loneliness in population-based studies.
Measured: Measured at baseline, weeks 12 and 52.
Self-reported sleep quality
Assessed from the questionnaire Pittsburgh Sleep Quality Index. The questionnaire consists of 19 items. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: Measured at baseline, weeks 12 and 52.
Self-reported self-efficacy for nutrition change
Assessed from the questionnaire Self-efficacy for nutrition change (SEFNC). SEFNC assesses individuals' confidence in their ability to maintain healthy eating habits in challenging situations over the next six months. The scale includes 9 items addressing common barriers such as emotional distress, lack of support, time pressure, and disrupted routines. Each item is rated on a percentage scale from 0% ("Not at all confident") to 100% ("Completely confident"), in 10% increments. A higher mean score indicates greater self-efficacy for sustaining nutrition-related behavior change.
Measured: Measured at baseline, weeks 12 and 52.
Self-reported social support for eating habits
Assessed from the questionnaire Social Support for Eating Habits Questionnaire. The questionnaire includes 10 items rated separately for family and friends, assessing both supportive and unsupportive behaviors related to dietary change. Items are rated on a scale from 1 (Not at all) to 5 (Very often), with 8 indicating "Not applicable." Higher scores on supportive items reflect greater perceived support; higher scores on unsupportive items reflect greater social barriers.
Measured: Measured at baseline, weeks 12 and 52.
Self-reported food addiction
Assessed from the questionnaire Yale food addiction scale (YFAS). It consists of 25 items evaluating symptoms such as loss of control over eating, continued use despite negative consequences, and withdrawal. The scale provides both a symptom count score (ranging from 0 to 11) and a diagnostic threshold indicating the presence of food addiction. Higher scores indicate more severe food addiction symptomatology. A diagnosis is assigned if a certain number of symptoms are endorsed along with clinically significant impairment or distress
Measured: Measured at baseline, weeks 12 and 52.
Adverse events
Number and description of adverse events and serious adverse events reported during the intervention period.
Measured: Through study completion, an average of 52 weeks.
Exercise intensity (%VO2peak)
Heart rate assessed from GPS-based smart watch and corresponding %VO2peak (measured at test visits).
Measured: Measured at baseline, weeks 12, 18, and 52.
Exercise intensity (Rate of Perceived Exertion Scale)
Rate of perceived Exertion on a 0 to 10 scale (0 being no exertion at all and 10 being a maximum effort).
Measured: 3 sessions pr. week, from week 13 to week 52.
Cardiac output - Mixed Meal Tolerance Test
Cardiac output (L/min) will be measured during the MMTT for 5 min using the non-invasive Finapres Nova device at minute -30 (pre-meal baseline), and at minutes 15, 45, 75, 105, 135, 195, 255.
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Systemic vascular resistance - Mixed Meal Tolerance Test
Systemic vascular resistance (dyn*s/cm5) will be measured during the MMTT for 5 min using the non-invasive Finapres Nova device at minute -30 (pre-meal baseline), and at minutes 15, 45, 75, 105, 135, 195, 255.
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Heart rate and its variability - Mixed Meal Tolerance Test
Heart rate (bpm) and heart rate variability (ms) will be measured during the MMTT for 5 min using the non-invasive Finapres Nova device at minute -30 (pre-meal baseline), and at minutes 15, 45, 75, 105, 135, 195, 255.
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Blood pressure and its variability - Mixed Meal Tolerance Test
Blood pressure and blood pressure variability (mmHg) will be measured during the MMTT for 5 min using the non-invasive Finapres Nova device at minute -30 (pre-meal baseline), and at minutes 15, 45, 75, 105, 135, 195, 255.
Measured: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Timing - sleep pattern
Sleep timing (hh:mm) will be measured with a GPS-based smartwatch and a thigh-mounted accelerometer (SENS Motion).
Measured: Measured from weeks 16-51 (GPS-based smartwatch) and at baseline, weeks 12, 18, and 52 (SENS Motion).
Duration - sleep pattern
Sleep duration (minutes) will be measured with a GPS-based smartwatch and a thigh-mounted accelerometer (SENS Motion).
Measured: Measured from weeks 16-51 (GPS-based smartwatch) and at baseline, weeks 12, 18 and 52 (SENS Motion).
Variability - sleep pattern
Sleep variability (minutes) will be measured with a GPS-based smartwatch and a thigh-mounted accelerometer (SENS Motion).
Measured: Measured from weeks 16-51 (GPS-based smartwatch) and at baseline, weeks 12, 18 and 52 (SENS Motion).
Efficiency - sleep pattern
Sleep efficiency (%) will be measured with a GPS-based smartwatch and a thigh-mounted accelerometer (SENS Motion).
Measured: Measured from weeks 16-51 (GPS-based smartwatch) and at baseline, weeks 12, 18 and 52 (SENS Motion).
Wakefulness - sleep pattern
Sleep wakefulness (%) will be measured with a GPS-based smartwatch and a thigh-mounted accelerometer (SENS Motion).
Measured: Measured from weeks 16-51 (GPS-based smartwatch) and at baseline, weeks 12, 18 and 52 (SENS Motion).
Home blood pressure
Systolic and diastolic blood pressure (mmHg) will be measured at home under resting conditions.
Measured: Measured at baseline, at weeks 1, 2, 3, 4, 8, 12, 18, 24, 30, 36, 42, 48, and 52.
Resting heart rate measured at home
Resting heart rate (bpm) will be measured at home under resting conditions
Measured: Measured at baseline, at weeks 1, 2, 3, 4, 8, 12, 18, 24, 30, 36, 42, 48, and 52.
Self-measured blood glucose
Capillary blood glucose (mmol/L) will be measured at home before the three main meals and at bedtime over two consecutive days.
Measured: Measured at baseline, at weeks 1, 2, 3, 4, 8, 12, 18, 24, 30, 36, 42, 48, and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start30 Sep 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The feasibility study is a 52-week, 2-arm open-label randomized diet and exercise trial including 24 individuals with newly diagnosed type 2 diabetes.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Steno Diabetes Center Odense, University of Copenhagen, The Novo Nordisk Foundation Center for Basic Metabolic Research, Bispebjerg Hospital
- Responsible party
- Principal investigator, Jonas Salling Quist, Steno Diabetes Center Copenhagen
- Investigators
- Jonas Salling Quist Senior Researcher and Associate Professor, PhD, Principal investigator, Steno Diabetes Center Copenhagen, University of Copenhagen - Department of Biomedical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262788
- Sponsor's protocol ID
- 1-10-72-77-25
- Acronym
- ON LiMiT
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes (ON LiMiT)
- ClinicalTrials.gov ID
- NCT07262788
- Acronym / sponsor ID
- ON LiMiT / 1-10-72-77-25
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 Diabetes, Obesity, Remission, Feasibility, Diet, Overweight, Lifestyle Intervention, Exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Steno Diabetes Center Odense, University of Copenhagen, The Novo Nordisk Foundation Center for Basic Metabolic Research, Bispebjerg Hospital
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of this study is to examine the feasibility of a 12-month, two-arm lifestyle intervention to induce and maintain remission of type 2 diabetes (T2D). The findings from the feasibility study will inform the recruitment, design and delivery of the interventions in a 5-arm, 24-month randomised controlled trial.
Detailed description
Studies on T2D remission have reported varying rates of remission, often around 50% in intervention groups. These studies typically involve individuals with a recent T2D diagnosis, usually within six to ten years of diagnosis, with intervention periods most commonly lasting between twelve and twenty-four months, though durations have ranged from six to sixty months. Lifestyle interventions combining dietary changes and increased physical activity generally yield modest remission rates, but maintaining adherence over time remains challenging. Trials that include an initial phase of a very low-calorie diet, followed by ongoing structured support, tend to report higher remission rates. This emphasizes the critical role of significant and sustained weight loss. However, the most effective combination of dietary, exercise, and behavioral support strategies remains to be determined.
In addition to calorie restriction, changes in dietary composition may influence the underlying mechanisms of T2D. For instance, reducing carbohydrate intake can promote ketone production, affecting liver glucose production and improving glycemic control. Higher protein intake has been linked to an improved insulin response. Replacing saturated fats with polyunsaturated fats and increasing dietary fiber may also support glucose metabolism. However, it remains unclear whether carbohydrate-reduced or carbohydrate-rich diets are more effective in supporting long-term remission following initial weight loss.
Physical activity, particularly high-intensity exercise, plays a key role in reducing the risk of T2D, supporting weight management, and improving remission rates when combined with dietary interventions. Significant improvements in blood glucose control are usually seen with regular moderate-to-high-intensity exercise.
Moreover, there is considerable variation-or sometimes an absence-in the inclusion of key lifestyle intervention components, such as specific dietary and exercise protocols, as well as levels of supportive activities. This inconsistency complicates effective care provision for healthcare professionals and makes it difficult for individuals with T2D to adhere to non-pharmacological management recommendations.
Despite the known benefits of lifestyle modifications, initiating and maintaining these changes is challenging due to barriers such as a lack of support, motivation, and knowledge about nutrition and portion sizes. Involving individuals with T2D in designing and evaluating interventions may improve adherence, reduce participant burden, and increase the feasibility and scalability of lifestyle programs for wider implementation.
The overall aim of this study is to examine the feasibility of a 12-month, two-arm intervention designed to induce and maintain remission of T2D. After baseline measurements, participants will be randomized to one of two groups: Group A: Very-low-calorie-diet (VLCD)/weight loss followed by a carbohydrate-reduced (CH-reduced) diet combined with high-intensity exercise. Group B: VLCD/weight loss followed by a carbohydrate-rich (CH-rich) diet combined with high-intensity exercise. Participants and study staff will be blinded to the intervention arm during the VLCD phase.
To determine the optimal macronutrient composition of the Mixed Meal Tolerance Test (MMTT) for subsequent testing, participants will undergo three different MMTTs consisting of 550 kcal in random order at baseline; a low-carbohydrate meal (27/30/43 energy percentage (E%) from carbohydrate/protein/fat), an intermediate-carbohydrate meal (40/23/37 E%), and a high-carbohydrate meal (53/17/30 E%). Postprandial responses to the intermediate-carbohydrate meal will be evaluated against those to the low- and high-carbohydrate meal in terms of glucose, insulin, C-peptide, free fatty acids, and triglycerides during 240 minutes. If the responses are deemed sufficiently favorable, the intermediate-carbohydrate meal will be selected for MMTTs conducted at weeks 12, 18, and 52.
Feasibility will be evaluated based on the recruitment process, intervention acceptability, and participant adherence. This includes assessing whether the intervention components and outcome measurements are delivered and conducted as intended. Additionally, the study will examine how these elements perform in a real-life setting among individuals with T2D. Findings from this feasibility study will inform recruitment strategies, study design, and implementation of a subsequent five-arm, 24-month randomized controlled trial.
Specific aims:
- To study the recruitment process (including recruitment of general practitioners and participants) and identify related barriers and facilitators.
- To investigate retention, adherence, and acceptability of the interventions (carbohydrate-reduced or carbohydrate-rich diet combined with high-intensity exercise), including participant experiences with the intervention components and data collection procedures.
- To assess whether the intervention is delivered as intended, covering supervised/unsupervised sessions, study visits, online support, and group education.
- To evaluate the effectiveness of safety procedures in responding to changes in participants' glycemic control, blood pressure, physical injuries, and related risk markers.
- To determine the optimal macronutrient composition and sampling schedule for the Mixed Meal Tolerance Test (MMTT).
- To explore the potential impact of the two interventions on T2D remission rates and related metabolic outcomes such as body weight, body composition, blood pressure, vascular function, glycemic control, lipid profile, beta-cell function, and inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The feasibility study is a 52-week, 2-arm open-label randomized diet and exercise trial including 24 individuals with newly diagnosed type 2 diabetes.
| Arm | Type | Receives |
|---|---|---|
| CH-rich diet with exercise | Experimental | Other: CH-rich diet with exerciseA CH-rich diet combined with an exercise programme (n=12) |
| CH-reduced diet with exercise | Experimental | Other: CH-reduced diet with exerciseA CH-redcued diet combined with an exercise programme (n=12) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of T2D. Treatment lifestyle changes, oral anti-diabetic medication including metformin, and/or sulfonylureas and/or DPP-4 inhibitors and/or SGLT2 inhibitors and/or incretin-based medication
- HbA1c between 36-86 mmol/mol
- T2D duration of ≤6 years
- BMI ≥27 kg/m2
- Body weight changes over 3 months ≤3 kg
Key exclusion criteria (13 listed)
- Insulin treatment within 6 months prior to screening (any type)
- Heart failure (ejection fraction ≤40%) and treated with SGLT-2i (current or planned)
- Cardiovascular disease, including previous heart attack or stroke, for which incretin-based therapy and/or an SGLT-2i has been prescribed.
- Kidney disease (eGFR <60 ml/min/1,73m² and/or albuminuria (≥30 mg/g) for at least three months) and treated with SGLT-2i (current or planned)
- Physical comorbidity, which precludes the physical activity during intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CH-rich diet with exerciseAfter 12 weeks of following a VLCD (Phase 1), participants begin a 6-week transition (Phase 2). During this phase, they adopt a CH-rich diet, consuming 50-55% of their total energy from carbohydrates. This involves shifting gradually but structurally from formula products to regular meals. Meal boxes and formula products aligned with their assigned diet support this shift and serve as educational tools. Phase 2 also includes an exercise program consisting of two supervised 1-hour sessions and one 1-hour unsupervised high-intensity session weekly (intensity >70% peak oxygen uptake (VO2peak) and/or >7 on the Rate of Perceived Exertion scale (RPE), equivalent to 1-3 repetitions in reserve for resistance training or vigorous intensity). For the next 34 weeks (Phase 3), participants receive ongoing diet and exercise support while purchasing and preparing their own meals according to their assigned diet. They continue with two supervised and one unsupervised group session per week. | Other | CH-rich diet with exercise |
| CH-reduced diet with exerciseAfter 12 weeks of following a VLCD (Phase1), participants begin a six-week transition (Phase 2 ). During this phase, they adopt a CH-reduced diet, consuming 25-30% of their total energy from carbohydrates. This involves shifting gradually but structurally from formula products to regular meals. Meal boxes and formula products aligned with their assigned diet support this shift and serve as educational tools. Phase 2 also includes an exercise program consisting of two supervised 1-hour sessions and one 1-hour unsupervised high-intensity session weekly (intensity >70% peak oxygen uptake (VO2peak) and/or >7 on the RPE scale, equivalent to 1-3 repetitions in reserve for resistance training or vigorous intensity). For the next 34 weeks (Phase 3), participants receive ongoing diet and exercise support while purchasing and preparing their own meals according to their assigned diet. They continue with two supervised and one unsupervised group session peer week. | Other | CH-reduced diet with exercise |
Primary outcome
Feasibility testing of diet adherence
Time frame: Baseline, weeks 18, 24, 36, and 52.
Derived from myfood24 dietary recalls collected over three consecutive days at pre-specified time points. A recall day is adherent if E% carbohydrate is within the arm-specific target ±10 E%. Participant-level percent compliance at each time point is calculated as (adherent recall days / valid recall days) × 100.
Feasibility testing of exercise adherence
Time frame: 3 sessions pr. week, from week 13 to 52.
Adherence is assessed based on self-report and measured (wearable heart rate monitor) using study app and calculated as number of completed sessions / total prescribed sessions.
Feasibility testing of GP recruitment & safety procedures - quantitative assessment
Time frame: Through study completion, an average of 52 weeks.
The recruitment of GPs will be assessed based on the number who express interest, attend instruction and sign collaboration agreements. The reasons for GP non-participation or withdrawal will be documented and, if possible, the GPs will be interviewed. Contacts with GPs that are safety-related, and their responses, including the outcomes of medication changes, will be recorded.
Feasibility testing of GP experiences and study procedures - qualitative assessment
Time frame: Through study completion, an average of 52 weeks.
Interviews with one GP or staff member from each participating clinic will explore experiences with study procedures, including barriers and opportunities related to recruitment and medication discontinuation, as well as any unintended consequences.
Feasibility testing of participant recruitment & retention
Time frame: Through study completion, an average of 52 weeks.
Registered numbers of: individuals expressing interest in the project, participants completing pre-screening (telephone interview) and in-person screening, participants included in the study, drop-outs and completers. Reasons for exclusion or withdrawal will be documented.
Feasibility testing of intervention participation - quantitative assessment
Time frame: Through study completion, an average of 52 weeks.
The degree of implementation of intervention activities and the extent of participant engagement will be measured by tracking attendance and completion of planned intervention components, including intervention visits, supervised and unsupervised exercise sessions, phone calls, at-home measurements, group-based education sessions, and peer support activities. Data will be collected via REDCap (8.10.18, Vanderbilt University, TN, USA) and study logs to quantify the proportion of completed versus scheduled activities for each participant.
Feasibility testing of intervention participation - qualitative assessment
Time frame: Through study completion, an average of 52 weeks.
Group-based diet and exercise sessions will be observed to assess how the intervention is delivered in practice and how participants engage with the activities. Field notes will document group dynamics, adherence to session protocols, and contextual factors. Field notes will also inform interview guides and supplement interview data.
Feasibility testing of protocol adherence - number of days with deviations
Time frame: Through study completion, an average of 52 weeks.
Total number of days during which participants did not adhere to the planned intervention protocol or experienced protocol deviations during the three intervention phases.
Feasibility testing of acceptability and experiences
Time frame: Through study completion, an average of 52 weeks plus a 3-month follow-up interview with participants.
Interviews with participants, dieticians and exercise instructors.
83 secondary outcomes
Evaluation of dietary screener to assess adherence
Time frame: Every 2 weeks from week 15 to week 52.
Dietary intake
Time frame: Measured at baseline, weeks 18, 24, 36, and 52.
Diabetes remission
Time frame: Measured at weeks 12, 18, 30, 42, and 52.
Body weight (kg)
Time frame: Changes from baseline to the end of the intervention measured at four time points (baseline, weeks 12, 18, and 52).
Achieved clinically relevant weight loss (≥10%)
Time frame: Measured at baseline, weeks 12, 18, and 52.
HbA1c (mmol/mol and %)
Time frame: Measured at screening, baseline, weeks 12, 18, 30, 42, and 52.
GAD65 Antibodies (U/mL)
Time frame: Measured at screening.
Marker of kidney function - eGFR (mL/min)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of kidney function - Creatinine (μmol/L)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of kidney function - Potassium (mmol/L)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of kidney function - Sodium (mmol/L)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Plasma Albumin (g/L)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Plasma Hemoglobin (g/L)
Time frame: Measured at baseline, weeks 12, 18, and 52.
White Blood Cells (10⁹/L)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Height (m)
Time frame: Measured at baseline.
Body weight (kg)
Time frame: Time frame: Collected once weekly from week 1 to 52.
Body mass index (kg/m^2)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Gut Microbiome Composition
Time frame: Collected at baseline, weeks 12, 18, and 52.
Urine spot samples for dietary biomarkers (home collection)
Time frame: Collected at weeks 18, 24, 36, 42, and 52
Urine Albumin-to-Creatinine Ratio (at site)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Saliva microbiome composition
Time frame: Collected at baseline, weeks 12, 18, and 52.
Metabolites - Mixed Meal Tolerance Test
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Glucometabolic and gut hormones (pmol/L and pmol/L*min) - Mixed Meal Tolerance Test
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Insulin Sensitivity - Mixed Meal Tolerance Test
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
β-Cell Function - Mixed Meal Tolerance Test
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Hepatic First-Pass Insulin Extraction - Mixed Meal Tolerance Test
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Metabolic Insulin Clearance - Mixed Meal Tolerance Test
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Subjective appetite sensations - Mixed Meal Tolerance Test
Time frame: Measured at baseline (using three differing meal compositions), and at weeks 12, 18 and 52 (using the selected meal composition).
Physical activity
Time frame: Measured at baseline, weeks 12, 18, and 52.
Waist circumference (cm)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Hip circumference (cm)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Waist/hip ratio
Time frame: Measured at baseline, weeks 12, 18, and 52.
Fat mass (kg)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Fat free mass (kg)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Fat percentage (%)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Bone mass (kg)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of liver function - Degree of liver fibrosis (kPa)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of liver function - Degree of liver steatosis (dB/m)
Time frame: Measured at baseline, weeks 12, 18, and 52.
Marker of liver function - FIB-4 Index
Time frame: Measured at baseline, weeks 12, 18, and 52.
Cognition
Time frame: Measured at baseline, weeks 12, and 52.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonas Salling Quist Senior Researcher and Associate Professor, PhD contact
Jonas Salling Quist Senior Researcher and Associate Professor, PhD principal investigator
Steno Diabetes Center Copenhagen, University of Copenhagen - Department of Biomedical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CH-rich diet with exercise and CH-reduced diet with exercise in people with Type 2 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonas Salling Quist Senior Researcher and Associate Professor, PhD (+45 26176064, jonas.salling.quist@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility testing of diet adherence (time frame: Baseline, weeks 18, 24, 36, and 52.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.