PrediabetesNCT07389005
Exercise, Chronotype, and Prediabetes
A study testing Timing of exercise in people with Prediabetes and Overweight , Obesity, run by German Diabetes Center at 1 site in Germany.
Trial summary
The goal of this clinical trial is to find out whether exercising at the right time of day, based on a person's natural body clock, leads to greater health benefits in people living with prediabetes. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Prediabetes, Overweight , Obesity
- What is being tested?
- Timing of exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2026to Aug 2028
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide signed and dated written informed consent prior to any study specific procedures
- Adult men and women aged between more than 18 and ≤ 75 years
- Body mass index (BMI) of 25 - 35 kg/m2
- Stable weight (no weight loss or gain > 3 kg in the past 3 months)
- Pre-diabetes defined as an isolated impaired glucose tolerance or a combination of impaired glucose tolerance and impaired fasting glucose (values are based on the American Diabetes Association (ADA):
- impaired glucose tolerance (plasma glucose 140 mg/dL to 199 mg/dL, 120 minutes after consumption of 75g of glucose)
- impaired fasting glucose (fasting plasma glucose 100 mg/dL to 125 mg/dL)
- Morning (Morningness-Eveningness Questionnaire [MEQ] score ≥ 59) or evening (MEQ score ≤ 41) chronotype
Who cannot join
- Previously diagnosed with type 2 diabetes
- Moderate to severe anemia (hemoglobin < 10 g/L)
- Uncontrolled hypertension
- Abnormal electrocardiogram (ECG) at rest judged by the study physician
- Pregnancy or breastfeeding
- HIV, hepatitis B, or C infection
Show all 17Show fewer
- Disorders of blood clotting or wound healing
- Positive history of venous thrombosis (contraindication for clamp)
- Hypersensitivity to local anesthetics (contraindication for fat/muscle biopsies)
- Night shift work in the last 3 months
- Travel across > 1 time zone in the last 3 months
- Participation in another clinical trials that may possibly hamper the study results
- Engagement in structured exercise activities > 2 hours a week
- Any acute condition, exacerbation of chronic condition, or medical history that in the investigator's opinion would interfere with the study
- Any contraindication for MRI scanning
- Medication use known to hamper safety during the study procedures
- Non-German speaking
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
German Diabetes Center (DDZ)
Düsseldorf, 40225
Friedrich C. Jassil, PhD, +49 211 3382-685, friedrich.jassil@ddz.de
About this study
Official title: Timed Exercise in Prediabetes With Extreme Chronotype
The goal of this clinical trial is to find out whether exercising at the right time of day, based on a person's natural body clock, leads to greater health benefits in people living with prediabetes. The main question it aims to answer is whether doing a single session of exercise in the morning or in the evening affects how the body handles sugar differently in adults with prediabetes who have an extreme natural body clock. This will be done by comparing three conditions (no-exercise, morning exercise, and evening exercise) within the same participant. Each condition will be tested on a different day, with at least 14 days between the test days. During the no-exercise test days, participants will come to the study centre and will only be allowed to do sedentary activities (e.g. office work, reading, or screen time). During the morning exercise test days, participants will perform an exercise session at 9:00 am that involves short periods of very hard effort followed by short rest periods. Whereas for the evening exercise test days, the same type of exercise will be performed at 5:00 pm.
Read the detailed description
Chronotype refers to an individual's circadian preferences for being active and fully functional at certain times of the day. Using validated questionnaires, individual's chronotype can be categorized to either a morning (lark), evening (owl), or intermediate (neutral) chronotypes. Individuals with morning chronotype wake up and go to bed early. Therefore, their calorie distribution as well as peak mental and physical performances predominantly occur earlier in the day. This is in contrast with individuals with evening chronotype that wake up and go to bed late, resulting in most of their calorie consumption happens later in the day. They are also more active and alert in the evening. Growing evidence has shown that late afternoon or evening exercise is better than morning exercise for blood glucose control in individuals with type 2 diabetes (T2D) or those at risk of T2D. In men with T2D, two weeks of high-intensity interval training (HIIT) reduced continuous glucose monitor (CGM)-based glucose concentration when performed in the afternoon than in the morning. This finding was further supported by a retrospective study involving men at risk for or T2D that found afternoon exercise led to superior peripheral insulin sensitivity, insulin-mediated suppression of adipose tissue lipolysis, and fasting plasma glucose. Interestingly, in a recently published crossover trial involving men and women, with and without T2D, no difference was observed in 24-hour glucose profile assessed using CGM across all cohorts (including gender and diabetes status) between morning and evening exercise. However, morning exercise increased post-exercise blood glucose levels during the two hours recovery period in both men and women with T2D, which was not observed following the evening exercise. It is important to note that all the above-mentioned studies are either excluding individuals with extreme chronotype or the chronotype of the participants was not clearly reported. This limitation raises an important research question: Do people living with extreme chronotype respond differently to timed exercise? Therefore, in this study, it is hypothesize that people living with prediabetes and extreme chronotype will gain superior metabolic benefits when the timing of exercise is aligned with their chronotype. To test this, a randomized controlled cross-over study is conducted in which participants are subjected to three conditions that are no-exercise, morning exercise, and evening exercise. The main outcome is insulin sensitivity determined by a 2-step hyperinsulinemic-euglycemic clamp.
- Conditions
- Prediabetes, Overweight , Obesity
- Being tested
- Timing of exercise, Control
- Keywords
- Prediabetes, Overweight, Obesity, Exercise, Chronotype
- Medical subject headings
- Prediabetic State, Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of exerciseBehavioural
An acute exercise bout of cycling performed in the morning at 9 AM
Timing of exerciseBehavioural
An acute exercise bout of cycling performed in the morning at at 5 PM
ControlBehavioural
No exercise
| Study group | Role | What they receive |
|---|---|---|
| AM exercise | Experimental | Behavioral: Timing of exercise Receives: Behavioral: Timing of exercise |
| PM exercise | Experimental | Behavioral: Timing of exercise Receives: Behavioral: Timing of exercise |
| Control | Active comparator | Behavioral: Control Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Effect of timed exercise on insulin sensitivity assessed using insulin sensitivity index (reported as M-value: mg x kg-1 x min-1) during an hyperinsulinemic-euglycemic clamp
Measured: 12 to 24 hours post-exercise intervention
Secondary outcomes (12)
Skeletal muscle metabolites
Effect of timed exercise on skeletal muscle mitochondrial respiration (pmol/mg/s) measured with high resolution respirometry
Measured: 12 to 24 hours post-exercise intervention
Skeletal muscle clock genes
Effect of timed exercise on quantified DNA measured with quantitative polymerase chain reaction (qPCR)
Measured: 12 to 24 hours post-exercise intervention
Adipose tissue metabolites
Effect of timed exercise on adipose tissue mitochondrial respiration (pmol/mg/s) measured with high resolution respirometry
Measured: 12 to 24 hours post-exercise intervention
Adipose tissue clock genes
Effect of timed exercise on quantified DNA measured with quantitative polymerase chain reaction (qPCR)
Measured: 12 to 24 hours post-exercise intervention
Hepatic glycogen content assessed using 13C Magnetic Resonance Spectroscopy
Effect of timed exercise on hepatic glycogen content, expressed in millimoles per liter (mmol/L) of liver tissue
Measured: Post-dinner on exercise day
Serum glucose
Effect of timed exercise on serum glucose levels (mg/dL) determined from venous blood draws
Measured: 12 to 24 hours post-exercise intervention
Serum free fatty acids
Effect of timed exercise on serum free fatty acid levels (mmol/L) determined from venous blood draws
Measured: 12 to 24 hours post-exercise intervention
Serum triglycerides
Effect of timed exercise on serum triglycerides (mg/dL) determined from venous blood draws
Measured: 12 to 24 hours post-exercise intervention
Serum cholesterol
Effect of timed exercise on serum cholesterol (mg/dL) determined from venous blood draws
Measured: 12 to 24 hours post-exercise intervention
Serum insulin
Effect of timed exercise on serum insulin levels (uIU/mL) determined from venous blood draws
Measured: 12 to 24 hours post-exercise intervention
Resting energy expenditure assessed using indirect calorimetry
Effect of timed exercise on resting energy expenditure, expressed in kilocalories per day (kcal/day)
Measured: 12 to 24 hours post-exercise intervention
Objective sleep quantity and quality assessed using an actighrapy device
Effect of timed exercise on sleep duration, efficiency, and fragmentation are measured objectively from the actighrapy device
Measured: The nighttime of exercise intervention day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Schrauwen, PhD, Principal investigator, German Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389005
- Sponsor's protocol ID
- REALIGN
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will only be discussed with other researcher on group level. We are not interested in sharing individual participant data.
Publications
Keller MJ, Brady AJ, Smith JAB, Savikj M, MacGregor K, Jollet M, Oberg SB, Nylen C, Bjornholm M, Rickenlund A, Carlsson M, Caidahl K, Krook A, Pillon NJ, Zierath JR, Wallberg-Henriksson H. Inflammatory markers and blood glucose are higher after morning vs afternoon exercise in type 2 diabetes. Diabetologia. 2025 Sep;68(9):2023-2035. doi: 10.1007/s00125-025-06477-5. Epub 2025 Jun 28.
PubMed 40580209Mancilla R, Brouwers B, Schrauwen-Hinderling VB, Hesselink MKC, Hoeks J, Schrauwen P. Exercise training elicits superior metabolic effects when performed in the afternoon compared to morning in metabolically compromised humans. Physiol Rep. 2021 Jan;8(24):e14669. doi: 10.14814/phy2.14669.
PubMed 33356015Savikj M, Gabriel BM, Alm PS, Smith J, Caidahl K, Bjornholm M, Fritz T, Krook A, Zierath JR, Wallberg-Henriksson H. Afternoon exercise is more efficacious than morning exercise at improving blood glucose levels in individuals with type 2 diabetes: a randomised crossover trial. Diabetologia. 2019 Feb;62(2):233-237. doi: 10.1007/s00125-018-4767-z. Epub 2018 Nov 13.
PubMed 30426166
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timed Exercise in Prediabetes With Extreme Chronotype
- ClinicalTrials.gov ID
- NCT07389005
- Acronym / sponsor ID
- REALIGN
- Conditions
- Prediabetes, Overweight , Obesity
- Keywords
- Prediabetes, Overweight, Obesity, Exercise, Chronotype
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- German Diabetes CenterUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 5 Feb 2026 (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 goal of this clinical trial is to find out whether exercising at the right time of day, based on a person's natural body clock, leads to greater health benefits in people living with prediabetes. The main question it aims to answer is whether doing a single session of exercise in the morning or in the evening affects how the body handles sugar differently in adults with prediabetes who have an extreme natural body clock. This will be done by comparing three conditions (no-exercise, morning exercise, and evening exercise) within the same participant. Each condition will be tested on a different day, with at least 14 days between the test days. During the no-exercise test days, participants will come to the study centre and will only be allowed to do sedentary activities (e.g. office work, reading, or screen time). During the morning exercise test days, participants will perform an exercise session at 9:00 am that involves short periods of very hard effort followed by short rest periods. Whereas for the evening exercise test days, the same type of exercise will be performed at 5:00 pm.
Detailed description
Chronotype refers to an individual's circadian preferences for being active and fully functional at certain times of the day. Using validated questionnaires, individual's chronotype can be categorized to either a morning (lark), evening (owl), or intermediate (neutral) chronotypes. Individuals with morning chronotype wake up and go to bed early. Therefore, their calorie distribution as well as peak mental and physical performances predominantly occur earlier in the day. This is in contrast with individuals with evening chronotype that wake up and go to bed late, resulting in most of their calorie consumption happens later in the day. They are also more active and alert in the evening. Growing evidence has shown that late afternoon or evening exercise is better than morning exercise for blood glucose control in individuals with type 2 diabetes (T2D) or those at risk of T2D. In men with T2D, two weeks of high-intensity interval training (HIIT) reduced continuous glucose monitor (CGM)-based glucose concentration when performed in the afternoon than in the morning. This finding was further supported by a retrospective study involving men at risk for or T2D that found afternoon exercise led to superior peripheral insulin sensitivity, insulin-mediated suppression of adipose tissue lipolysis, and fasting plasma glucose. Interestingly, in a recently published crossover trial involving men and women, with and without T2D, no difference was observed in 24-hour glucose profile assessed using CGM across all cohorts (including gender and diabetes status) between morning and evening exercise. However, morning exercise increased post-exercise blood glucose levels during the two hours recovery period in both men and women with T2D, which was not observed following the evening exercise. It is important to note that all the above-mentioned studies are either excluding individuals with extreme chronotype or the chronotype of the participants was not clearly reported. This limitation raises an important research question: Do people living with extreme chronotype respond differently to timed exercise? Therefore, in this study, it is hypothesize that people living with prediabetes and extreme chronotype will gain superior metabolic benefits when the timing of exercise is aligned with their chronotype. To test this, a randomized controlled cross-over study is conducted in which participants are subjected to three conditions that are no-exercise, morning exercise, and evening exercise. The main outcome is insulin sensitivity determined by a 2-step hyperinsulinemic-euglycemic clamp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AM exercise | Experimental | Behavioral: Timing of exerciseBehavioral: Timing of exercise |
| PM exercise | Experimental | Behavioral: Timing of exerciseBehavioral: Timing of exercise |
| Control | Active comparator | Behavioral: ControlBehavioral: Control |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to provide signed and dated written informed consent prior to any study specific procedures
- Adult men and women aged between more than 18 and ≤ 75 years
- Body mass index (BMI) of 25 - 35 kg/m2
- Stable weight (no weight loss or gain > 3 kg in the past 3 months)
- Pre-diabetes defined as an isolated impaired glucose tolerance or a combination of impaired glucose tolerance and impaired fasting glucose (values are based on the American Diabetes Association (ADA):
Key exclusion criteria (17 listed)
- Previously diagnosed with type 2 diabetes
- Moderate to severe anemia (hemoglobin < 10 g/L)
- Uncontrolled hypertension
- Abnormal electrocardiogram (ECG) at rest judged by the study physician
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Timing of exerciseAn acute exercise bout of cycling performed in the morning at 9 AM | Behavioural | AM exercise |
| Timing of exerciseAn acute exercise bout of cycling performed in the morning at at 5 PM | Behavioural | PM exercise |
| ControlNo exercise | Behavioural | Control |
Primary outcome
Insulin sensitivity
Time frame: 12 to 24 hours post-exercise intervention
Effect of timed exercise on insulin sensitivity assessed using insulin sensitivity index (reported as M-value: mg x kg-1 x min-1) during an hyperinsulinemic-euglycemic clamp
12 secondary outcomes
Skeletal muscle metabolites
Time frame: 12 to 24 hours post-exercise intervention
Skeletal muscle clock genes
Time frame: 12 to 24 hours post-exercise intervention
Adipose tissue metabolites
Time frame: 12 to 24 hours post-exercise intervention
Adipose tissue clock genes
Time frame: 12 to 24 hours post-exercise intervention
Hepatic glycogen content assessed using 13C Magnetic Resonance Spectroscopy
Time frame: Post-dinner on exercise day
Serum glucose
Time frame: 12 to 24 hours post-exercise intervention
Serum free fatty acids
Time frame: 12 to 24 hours post-exercise intervention
Serum triglycerides
Time frame: 12 to 24 hours post-exercise intervention
Serum cholesterol
Time frame: 12 to 24 hours post-exercise intervention
Serum insulin
Time frame: 12 to 24 hours post-exercise intervention
Resting energy expenditure assessed using indirect calorimetry
Time frame: 12 to 24 hours post-exercise intervention
Objective sleep quantity and quality assessed using an actighrapy device
Time frame: The nighttime of exercise intervention day
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 11 Sep 2026.
- Background: PubMed 40580209Keller MJ, Brady AJ, Smith JAB, Savikj M, MacGregor K, Jollet M, Oberg SB, Nylen C, Bjornholm M, Rickenlund A, Carlsson M, Caidahl K, Krook A, Pillon NJ, Zierath JR, Wallberg-Henriksson H. Inflammatory markers and blood glucose are higher after morning vs afternoon exercise in type 2 diabetes. Diabetologia. 2025 Sep;68(9):2023-2035. doi: 10.1007/s00125-025-06477-5. Epub 2025 Jun 28.
- Background: PubMed 33356015Mancilla R, Brouwers B, Schrauwen-Hinderling VB, Hesselink MKC, Hoeks J, Schrauwen P. Exercise training elicits superior metabolic effects when performed in the afternoon compared to morning in metabolically compromised humans. Physiol Rep. 2021 Jan;8(24):e14669. doi: 10.14814/phy2.14669.
- Background: PubMed 30426166Savikj M, Gabriel BM, Alm PS, Smith J, Caidahl K, Bjornholm M, Fritz T, Krook A, Zierath JR, Wallberg-Henriksson H. Afternoon exercise is more efficacious than morning exercise at improving blood glucose levels in individuals with type 2 diabetes: a randomised crossover trial. Diabetologia. 2019 Feb;62(2):233-237. doi: 10.1007/s00125-018-4767-z. Epub 2018 Nov 13.
- Individual participant dataSharing planned: No. Participant data will only be discussed with other researcher on group level. We are not interested in sharing individual participant data.
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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.
Patrick Schrauwen, PhD principal investigator
German Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of exercise in people with Prediabetes and Overweight , Obesity, run by German Diabetes Center at 1 site in Germany.
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 17 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 11 Sep 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 Germany. 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 Patrick Schrauwen, PhD (+49 211 3382-689, patrick.schrauwen@ddz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 12 to 24 hours post-exercise intervention). 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 NCT07389005, which also lists 3 linked publications.
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 11 Sep 2026.