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Prediabetes / Type 2 DiabetesKRONODIABETNCT06783218

An Integrative Study of the Role of Microbiome, Metabolome, Transcriptome and Chronobiology in the Context of Type 2 Diabetes.

An observational study of Prediabetes / Type 2 Diabetes and Obesity and Overweight, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this descriptive clinical study is to investigate daily oscillations in glycaemic control between healthy adults and adults with excess weight and who have early-stage prediabetes or T2D and are not taking medications for glycaemic control. Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
How many people
36 participants
Where
1 siteSpain
Study dates
21 Mar 2024to 28 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

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 30 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Individuals from a region in the north of Spain. People registered in the Nutrition Research Centre's own database will be invited. In addition, other recruitment channels will be used, such as flyers, advertisements in local press, medical centres and hospitals, social networks and websites.

Who may be able to join

  • Women and men between the ages of 30 and 70.
  • Meet any criteria diagnosis of prediabetes or type 2 diabetes according to the American Diabetes Association (ADA), without pharmacological treatment for glycaemic control.
  • Excess weight, according to body mass index (BMI) value > 25 kg/m2.
  • Body fat percentage, measured by bioelectrical impedance analysis (BIA), above the normal range, according to age and sex, following the classification from Gallagher D, et al. Am J Clin Nutr. 2000;72(3):694-701.
  • Women and men between the ages of 30 and 70.
  • No impaired glucose metabolism according to ADA diagnostic criteria
  • Normal weight, according to BMI value (18,5 - 24,9 kg/m2)
  • Body fat percentage, measured by BIA, within the normal range, according to age and sex, following the classification from Gallagher D, et al. Am J Clin Nutr. 2000;72(3):694-701.

Who cannot join

  • Chronotype within the categories "extreme evening" (<34) or "extreme morning" (>76), according to the Hörne-Orberg Morning-Evening Questionnaire (MEQ) classification.
  • Weight changes (± 4.5 kg) during the last 3 months.
  • Habitually consuming ≥ 14 units of alcohol/week in women and ≥ 21 units of alcohol/week in men.
  • Self-reported use of drugs of abuse in the last 12 months.
  • Be an active smoker or have quit smoking within the last 3 months.
  • Night or late shift work (finishing later than 11 pm on a permanent basis).
Show all 29Show fewer
  • Recent travel across 2 or more time zones during the last month before the start of the study.
  • Show poor cooperation or, in the opinion of the investigator, have difficulty following the study procedures.
  • In the case of women, being pregnant or breastfeeding .
  • Blood donation in the 3 months prior to the beginning of the study.
  • Medical conditions:
  • Oral diseases, inflammation or lesions at the time of the study.
  • Any clinical condition, including chronic metabolic diseases, systemic intestinal, hepatic or renal diseases, when the research team consider that it may influence the results of the study.
  • Severe hyperlipidaemia, severe hypertension or hypothyroidism, untreated or treated for less than 3 months with stable dose.
  • Have relevant functional or structural abnormalities of the digestive tract, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory diseases or malabsorption.
  • Subjects who have undergone surgery of the digestive tract with permanent sequelae, including surgical treatment for obesity.
  • Any type of psychological/psychiatric impairment such as depressive pathology, anxiety or bipolar disorder, when the research team consider that it may influence the results of the study.
  • Any type of cancer or be undergoing treatment for it, or that a period of at least 5 years has not elapsed since its eradication.
  • A diagnosed eating disorder (such as bulimia or binge eating disorder)
  • Presence of any type of health problem that may affect sleep
  • Any infection at the time of the study, especially respiratory or intestinal infection.
  • Medication:
  • Be under continuous pharmacological/hormonal treatment that may affect glycaemic control.
  • Current or within the previous 2 months use of prescription or non-prescription medication or nutritional supplements that have the potential to affect glycaemic control, as well as biochemical analyses. For food supplements containing biotin, they are permitted provided that their consumption is omitted 48 h before blood draws.
  • Current or within the previous 2 months use of nutritional supplements or prescription or non-prescription drugs that may affect the microbiota (probiotics, prebiotics, fibre, antibiotics, antifungals).
  • Taking any medication that may seriously affect circadian rhythms (melatonin receptor agonist drugs (tasimelteon, ramelteon), drugs for the treatment of drowsiness (modafinil, armodafinil), or with sedative effects (benzodiazepines, zolpidem)) or nutritional supplements that contain melatonin and are likely to affect circadian rhythms, except if on a stable dose for 3 months or more.
  • Cholesterol-lowering medication, except if on a stable dose for 3 months or more.
  • Blood pressure lowering medication, unless on a stable dose for 3 months or more.
  • Medication that may affect appetite and body weight (e.g. antidepressants, thyroid) unless on a stable dose for 3 months or more and without significant side effects.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Center for Nutrition Research. University of Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: An Integrative Study of the Role of the Microbiome, Metabolome, Transcriptome and Chronobiology in the Context of Type 2 Diabetes.

The goal of this descriptive clinical study is to investigate daily oscillations in glycaemic control between healthy adults and adults with excess weight and who have early-stage prediabetes or T2D and are not taking medications for glycaemic control. The study also explores how these differences relate to changes in daily patterns in oral microbiome and metabolome, circadian markers, and lifestyle factors such as eating, physical activity, light exposure and appetite.

The main questions to answer are:

Read more
  1. Do adults with excess weight and prediabetes/T2D exhibit a disruption of the circadian system compared to healthy individuals? If so, are these disruptions manifested in hormone levels, gene expression, microbiota composition and function, metabolite levels and appetite regulation?
  2. Does chrono-disruption contribute to the dysregulation of glucose metabolism and responses to lifestyle factors in individuals with excess weight and prediabetes/T2D?

Researchers will compare two groups:

  • Healthy adults with normal weight.
  • Adults with excess weight (overweight or obesity) with prediabetes/T2D who are not on diabetes medications.

The study will involve both semi-controlled settings (where food intake and physical activity are controlled) and free-living conditions.

Participants will:

  • Wear devices: Use a continuous glucose monitor and a circadian monitoring device for 14 days.
  • Attend clinical visits: Visit the Nutritional Intervention Unit (NIU) 4 times for body composition measurements, sample collection (blood, saliva a faeces) and to answer questionnaires. .
  • Participate in a 12.5-hours clinical visit day in the NIU under semi-controlled conditions, with the purpose of collecting blood samples before and after breakfast and saliva samples every 4 hours, covering a full 24-hour cycle.
  • Keep track of daily habits: Maintain their usual lifestyle while keeping a food diary and recording appetite related feelings.
Read the detailed description

Compelling evidence suggests that type 2 diabetes (T2D) can often be prevented by adopting healthy lifestyle. However, current standard recommendations may not fully account for individual differences, limiting their effectiveness. Factors such as genetics and daily lifestyle patterns influence how individuals respond to these recommendations. For example, disrupted sleep patterns or irregular eating schedules can make it difficult to maintain healthy habits, ultimately affecting blood glucose control. Such disruptions are associated with disturbances in the body's internal clock, also known as circadian rhythms. In this sense, chrono-disruption (i.e., disruption of circadian rhythms) has been shown to impair glucose metabolism. Individuals at high risk of T2D are characterized by loss of diurnal rhythmicity in the insulin oscillatory pattern. Similarly, recent studies suggest that disruptions in daily fluctuations of hormone levels, gene expression, microbiota composition, and metabolite profiles are associated with poorer blood glucose control.

The present project relies on the hypothesis that individuals with excess weight and drug-naïve prediabetes or type 2 diabetes, compared to healthy individuals, exhibit a disruption of the circadian system. This is manifested by loss in daily oscillations and altered oscillatory patterns across multiple physiological processes, including hormone production, gene expression, microbiota composition and function, and metabolite composition and secretion. Chrono disruption contributes to the dysregulation of glucose metabolism, changes in appetite regulation and response to external cues and, consequently, impaired glycaemic control in this population.

The Kronodiabet study is a 2-week observational study with two parallel study groups, matched by age and gender, according to the following conditions: adults with overweight or obesity and impaired glucose metabolism (drug-naive prediabetes or type 2 diabetes); and adults with normal weight and no alterations in glucose metabolism.

Experimental design: Each participant, once recruited, will attend the NIU at the Center for Nutrition Research of the University of Navarra on 4 occasions. At visit 1 (V1), participants will come to the NIU and will be fitted with a continuous glucose monitoring sensor and a circadian monitoring device, which will be worn during the main study visit (V2) and the following 12 ± 2 full days (field period phase) and body composition will be analysed through dual energy x-ray absorptiometry (DEXA). At this visit (V1), participants will bring a stool sample collected no later than 48 hours prior to arrival at the NIU. In visit 2 (V2), lasting 12 hours and 30 minutes, participants will arrive to the NIU (where the entire visit will take place) after at least 8 hours of fasting. During this visit, participants will be provided with the meals to be consumed throughout the day and blood draws and completion of questionnaires will be carried out. In addition, 4 out of the 7 saliva samples required for the analysis of the oral microbiota, metabolome and gene and hormone determination will be collected every 4 hours. The remaining saliva samples (3/7) will be collected at home, until the 24-hour period is completed. On the following day (V3), participants will come back to the NIU to deliver the samples collected at home. In addition, they will be given the necessary material for the field study period. During the field phase (which will last 2 weeks) participants will be asked not to change their habitual lifestyle, including diet, exercise and timing. In the final visit (V4), body composition measurements will be taken and the circadian and glucose monitoring sensors and completed questionnaires will be collected, concluding the study.

The specific objectives are:

  1. To characterize the phenotype, behavioral traits and lifestyle habit, as well as the microbiome, metabolome and transcriptome in healthy individuals and individuals with overweight/obesity and drug-naïve prediabetes/type 2 diabetes.
  2. To investigate, under free-living conditions, daily oscillations in glycaemia, food behavior and circadian parameters of the main circadian synchronizers.
  3. To compare daily oscillations in oral microbiota and metabolome, along with daily oscillations of circadian markers, under semi-controlled conditions, between healthy individuals and individuals with overweight/obesity and drug-naïve prediabetes/type 2 diabetes.
  4. To study, from an integrated perspective, daily oscillations in glycemic control, through the integration of omics (metagenomics, metabolomics), clinical and lifestyle data, in the absence and presence of excess weight and impaired glucose metabolism.
Keywords
prediabetes, type 2 diabetes, obesity, microbiome, metabolome, eating behaviour, circadian rhythm, glycaemic control
Medical subject headings
Prediabetic State, Diabetes Mellitus, Type 2, Obesity, Overweight, Insulin Resistance, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06783218
Study groupRoleWhat they receive
Prediabetes/type 2 diabetesIndividuals with excess weight (overweight or obesity) and drug-naïve prediabetes or type 2 diabetes.
ControlsInvididuals without glycaemic control impairment and normal weight, matched on sex and age with the prediabetes/type 2 diabetes group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage coefficient of variation of intra-day glucose levels (%CV)

    Measured by continuous glucose monitoring sensor during semi-controlled conditions in the main clinical investigation day (%)

    Measured: Clinical Investigation Day 2 (24-hours)

Secondary outcomes (54)

  1. Glycaemic variation

    Measured by continuous glucose monitor (FreeStyle Libre Pro, Abbott)

    Measured: 14 days

  2. Glycated haemoglobin (HbA1c)

    Blood samples, reported in % and in mmol/mol. For screening purposes, HbA1c will also be determined using capillary blood samples at the screening visit.

    Measured: Screening, Clinical Investigation Day 2

  3. Fasting serum glucose

    Serum samples, reported in mg/dl

    Measured: Screening, Clinical Investigation Day 2

  4. Postprandial serum glucose

    Serum samples, reported in mg/dl, collected every 30 minutes for 2 hours after consuming breakfast. iAUC will be calculated including blood sample collected at baseline.

    Measured: Clinical Investigation Day 2, blood samples taken every 30 min for 2 hours (4 timepoints in total)

  5. Fasting serum insulin

    Serum samples, reported in mU/L, determined by ELISA

    Measured: Clinical Investigation Day 2

  6. Postprandial serum insulin

    Serum samples, reported in mU/L, collected every 30 minutes for 2 hours after consuming breakfast, determined by ELISA. iAUC will be calculated including blood sample collected at baseline.

    Measured: Clinical Investigation Day 2, blood samples taken every 30 min for 2 hours (4 timepoints in total)

  7. Fasting serum Peptide C

    Serum samples, reported in ng/mL, determined by ELISA

    Measured: Clinical Investigation Day 2

  8. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR)

    Calculated as (fasting basal insulin (mU/mL) x fasting glucose (mg/dL)/405

    Measured: Clinical Investigation Day 2

  9. Fasting serum total cholesterol

    Serum samples, reported in mg/dL

    Measured: Clinical Investigation Day 2

  10. Fasting serum HDL cholesterol

    Serum samples, reported in mg/dL

    Measured: Clinical Investigation Day 2

  11. Fasting serum LDL cholesterol

    Calculated using Friedewald's equation: total cholesterol - (triglycerides/5) - HDL-cholesterol

    Measured: Clinical Investigation Day 2

  12. Fasting serum triglycerides

    Serum samples, reported in mg/dL

    Measured: Clinical Investigation Day 2

  13. Postprandial serum triglycerides

    Serum samples, reported in mg/dL, collected every 30 minutes for 2 hours after consuming breakfast. iAUC will be calculated including blood sample collected at baseline.

    Measured: Clinical Investigation Day 2, blood samples taken every 30 min for 2 hours (4 timepoints in total)

  14. Fasting serum alanine aminotransferase (ALT)

    Fasting serum samples, reported in U/L

    Measured: Clinical Investigation Day 2

  15. Fasting serum aspartate aminotransferase (AST)

    Fasting serum samples, reported in U/L

    Measured: Clinical Investigation Day 2

  16. Fasting serum gamma-glutamyl transferase (GGT)

    Fasting serum samples, reported in U/L

    Measured: Clinical Investigation Day 2

  17. Triglyceride-glucose index (TyG index)

    Calculated using the following equation: Ln [(fasting triglycerides) (mg/dL) x fasting glucose (mg/dL)] / 2

    Measured: Clinical Investigation Day 2

  18. Fatty Liver Index (FLI)

    Calculated using the following equation: (e0.953×loge(triglycerides)+0.139×BMI+0.718×loge(GGT)+0.053×waistcircumference-15.745)/ (1 + e0.953×loge(triglycerides)+0.139×BMI+0.718×loge(GGT)+0.053×waistcircumference-15.745) × 100.

    Measured: Clinical Investigation Day 2

  19. Fasting serum/plasma glucagon-like peptide-1 (GLP-1)

    Serum/plasma samples, reported in pmol/L, determined by ELISA

    Measured: Clinical Investigation Day 2

  20. Postprandial serum/plasma glucagon-like peptide-1 (GLP-1)

    Serum/plasma samples, reported in pmol/L, collected every 30 minutes for 2 hours after consuming breakfast, determined by ELISA. iAUC will be calculated including blood sample collected at baseline.

    Measured: Clinical Investigation Day 2, blood samples taken every 30 min for 2 hours (4 timepoints in total)

  21. Fasting serum/plasma ghrelin

    Serum/plasma samples, reported in pmol/L

    Measured: Clinical Investigation Day 2

  22. Postprandial serum/plasma ghrelin

    Serum/plasma samples, reported in pmol/L, collected every 30 minutes for 2 hours after consuming breakfast, determined by ELISA. iAUC will be calculated including blood sample collected at baseline.

    Measured: Clinical Investigation Day 2, blood samples taken every 30 min for 2 hours (4 timepoints in total)

  23. Fasting serum/plasma leptin

    Serum/plasma samples, reported in ng/mL

    Measured: Clinical Investigation Day 2

  24. Hemogram

    Blood samples collected at fasting state

    Measured: Clinical Investigation Day 2

  25. Daily rhythms of wrist temperature fragmentation

    Wrist temperature will be measured using a circadian monitoring device (Kronowise 3.0) and the circadian parameter fragmentation will be calculated as intradaily variability.

    Measured: Clinical Investigation Day 2 (24-hours) and 14 days (field phase)

  26. Daily rhythms of wrist temperature regularity

    Wrist temperature will be measured using a circadian monitoring device (Kronowise 3.0) and the circadian parameter regularity will be calculated as interdaily stability.

    Measured: Clinical Investigation Day 2 (24-hours) and 14 days (field phase)

  27. Daily rhythms of wrist temperature amplitude

    Wrist temperature will be measured using a circadian monitoring device (Kronowise 3.0) and the circadian parameter amplitude will be calculated as relative amplitude and normalised relative amplitude.

    Measured: Clinical Investigation Day 2 (24-hours) and 14 days (field phase)

  28. Daily rhythms of circadian light exposure

    Circadian light exposure intensity, expressed as lux, will be measured using a circadian monitoring device (Kronowise 3.0)

    Measured: Clinical Investigation Day 2 (24-hours) and 14 days (field phase)

  29. Daily rhythms of visible light exposure

    Visible light exposure intensity, expressed as lux, will be measured using a circadian monitoring device (Kronowise 3.0)

    Measured: Clinical Investigation Day 2 (24-hours) and 14 days (field phase)

  30. Daily rhythms of activity

    Activity, measured as acceleration, will be determined using a circadian monitoring device (Kronowise 3.0)

    Measured: Clinical Investigation Day 2 (24-hours) and 14 days (field phase)

  31. Daily rhythms of time in movement

    Time in movement will be determined using a circadian monitoring device (Kronowise 3.0)

    Measured: Clinical Investigation Day 2 (24-hours) and 14 days (field phase)

  32. Integrated variable TAP (Temperature, Motor activity, Body Position)

    TAP will be determined by integrating three simultaenous recordings: skin wrist temperature (T), motor activity (A) and body position (P) from a circadian monitoring device (Kronowise 3.0) to determine individual circadian system status (i.e., chronotype)

    Measured: Clinical Investigation Day 2 (24-hours) and 14 days (field phase)

  33. Baseline and change from baseline in body weight at the end of the study

    Measured by bioimpedance and reported in kg

    Measured: Clinical Investigation Day 2 (week 0) and Clinical Investigation Day 4 (week 2)

  34. Height

    Measured by stadiometer and reported in m

    Measured: Screening (V0) and Clinical Investigation Day 1 (V1)

  35. Baseline and change from baseline in body mass index at the end of the study

    Body mass index will be calculated as follows: weight (kilograms)/(height (m)*height (m)), and expressed as kg/m2

    Measured: Clinical Investigation Day 2 (week 0) and Clinical Investigation Day 4 (week 2)

  36. Baseline and change from baseline in body fat at the end of the study

    Measured by bioimpedance and DXA (only at baseline) and reported in kg and percentage.

    Measured: Clinical Investigation Day 2 (week 0) and Clinical Investigation Day 4 (week 2)

  37. Baseline and change from baseline in body fat-free mass at the end of the study

    Measured by bioimpedance and DXA (only at baseline) and reported in kg.

    Measured: Clinical Investigation Day 2 (week 0) and Clinical Investigation Day 4 (week 2)

  38. Baseline and change from baseline in lean mass at the end of the study

    Measured by bioimpedance and DXA (only at baseline) and reported in kg.

    Measured: Clinical Investigation Day 2 (week 0) and Clinical Investigation Day 4 (week 2)

  39. Baseline and change from baseline in body water at the end of the study

    Measured by bioimpedance and reported in kg.

    Measured: Clinical Investigation Day 2 (week 0) and Clinical Investigation Day 4 (week 2)

  40. Baseline and change from baseline in waist circumference at the end of the study

    Measured in fasting condition using a measuring tape and reported in centimeters

    Measured: Clinical Investigation Day 2 (week 0) and Clinical Investigation Day 4 (week 2)

  41. Baseline and change from baseline in hip circumference at the end of the study

    Measured in fasting condition using a measuring tape and reported in centimeters

    Measured: Clinical Investigation Day 2 (week 0) and Clinical Investigation Day 4 (week 2)

  42. Baseline and change from baseline in visceral fat level at the end of the study

    Measured in fasting condition by bioimpedance and expressed as level (from 0 to 40).

    Measured: Clinical Investigation Day 2 (week 0) and Clinical Investigation Day 4 (week 2)

  43. Android adipose tissue

    Determined by DXA and expressed as percentage of total body fat and fat mass in grams.

    Measured: Clinical Investigation Day 1 (V1)

  44. Gynoid adipose tissue

    Determined by DXA and expressed as percentage of total body fat and fat mass in grams.

    Measured: Clinical Investigation Day 1 (V1)

  45. Gynoid lean tissue

    Determined by DXA and expressed as percentage of total lean mass and lean mass in grams.

    Measured: Clinical Investigation Day 1 (V1)

  46. Android lean tissue

    Determined by DXA and expressed as percentage of total lean mass and lean mass in grams.

    Measured: Clinical Investigation Day 1 (V1)

  47. Ratio trunk/total fat mass

    Determined by DXA and calculated as the ratio of trunk fat to total body fat.

    Measured: Clinical Investigation Day 1 (V1)

  48. Ratio legs/total fat mass

    Determined by DXA and calculated as the ratio of legs fat to total body fat.

    Measured: Clinical Investigation Day 1 (V1)

  49. Visceral adipose tissue volume and mass

    Determined by DXA and expressed as volume, in cm3, and mass, in grams.

    Measured: Clinical Investigation Day 1 (V1)

  50. Salivary cortisol determinations

    Saliva samples shall be collected every 4 hours for 24 hours, starting at 8 a.m. in the laboratory and ending at 8 a.m. the following day at home. Samples shall be collected by active salivation using a sample collection device, which contains a cotton swab.

    Measured: Clinical Investigation Day 2 (V2); saliva samples taken every four hour for 24 hours (7 time points in total)

  51. Salivary melatonin determinations

    Saliva samples shall be collected every 4 hours for 24 hours, starting at 8 a.m. in the laboratory and ending at 8 a.m. the following day at home. Samples shall be collected by active salivation using a sample collection device, which contains a cotton swab.

    Measured: Clinical Investigation Day 2 (V2); saliva samples taken every four hour for 24 hours (7 time points in total)

  52. Oscillations in the expression of clock genes in saliva

    Saliva samples shall be collected every 4 hours for 24 hours, starting at 8 a.m. in the laboratory and ending at 8 a.m. the following day at home. Samples shall be collected by passive drainage using a sample collection device, which contains a RNA/DNA preservative. Gene expression analyses will be performed by Real Time Polymerase Chain Reaction (RT-PCR) and quantified as relative expression compared to housekeeping genes.

    Measured: Clinical Investigation Day 2 (V2); saliva samples taken every four hour for 24 hours (7 time points in total)

  53. Oral microbial community composition rhythmicity

    Saliva samples shall be collected every 4 hours for 24 hours, starting at 8 a.m. in the laboratory and ending at 8 a.m. the following day at home. Samples shall be collected by passive drainage using a sample collection device, which contains a RNA/DNA preservative. Shotgun sequencing/16S sequencing will be performed for the metagenomic analysis and microbiota rhythmicity will be investigated.

    Measured: Clinical Investigation Day 2 (V2); saliva samples taken every four hour for 24 hours (7 time points in total)

  54. Oral metabolite rhythmicity

    Saliva samples shall be collected every 4 hours for 24 hours, starting at 8 a.m. in the laboratory and ending at 8 a.m. the following day at home. Samples will be collected by active salivation using a sample collection device, which contains a cotton swab. Oral metabolome profile will be assessed by broad-spectrum, untargeted metabolomics.

    Measured: Clinical Investigation Day 2 (V2); saliva samples taken every four hour for 24 hours (7 time points in total)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2025
  2. Study start21 Mar 2024
  3. Primary completion15 Oct 2024
  4. Study completion28 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06783218
Sponsor's protocol ID
KRONODIABET
Acronym
KRONODIABET
Status last verified
Dec 2024
First submitted
18 Dec 2024
Last updated
20 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Prediabetes / Type 2 Diabetes and Obesity and Overweight, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

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 8 inclusion and 29 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: finished, as of the sponsor's last update on 20 Jan 2025. 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 Spain. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage coefficient of variation of intra-day glucose levels (%CV) (time frame: Clinical Investigation Day 2 (24-hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06783218.

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 20 Jan 2025.

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