Exercise timing for people with prediabetes and overweight/obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with prediabetes who are overweight or mildly obese will try three conditions on different days: no exercise, morning exercise, and evening exercise, with at least 14 days between days. Morning exercise will occur at 9:00 am and involve intervals of hard effort followed by short rests; the evening session timing is designed to align with chronotype. The order of conditions is randomized, and safety and metabolic responses will be monitored in a research setting. The goal is to see if aligning exercise timing with a person’s chronotype improves glucose handling. This study uses a crossover design to compare each participant across the three conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able to provide signed and dated written informed consent prior to any study specific procedures
2. Adult men and women aged between more than 18 and ≤ 75 years
3. Body mass index (BMI) of 25 - 35 kg/m2
4. Stable weight (no weight loss or gain \> 3 kg in the past 3 months)
5. 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):

   1. impaired glucose tolerance (plasma glucose 140 mg/dL to 199 mg/dL, 120 minutes after consumption of 75g of glucose)
   2. impaired fasting glucose (fasting plasma glucose 100 mg/dL to 125 mg/dL)
6. Morning (Morningness-Eveningness Questionnaire \[MEQ\] score ≥ 59) or evening (MEQ score ≤ 41) chronotype

Exclusion Criteria:

1. Previously diagnosed with type 2 diabetes
2. Moderate to severe anemia (hemoglobin \< 10 g/L)
3. Uncontrolled hypertension
4. Abnormal electrocardiogram (ECG) at rest judged by the study physician
5. Pregnancy or breastfeeding
6. HIV, hepatitis B, or C infection
7. Disorders of blood clotting or wound healing
8. Positive history of venous thrombosis (contraindication for clamp)
9. Hypersensitivity to local anesthetics (contraindication for fat/muscle biopsies)
10. Night shift work in the last 3 months
11. Travel across \> 1 time zone in the last 3 months
12. Participation in another clinical trials that may possibly hamper the study results
13. Engagement in structured exercise activities \> 2 hours a week
14. Any acute condition, exacerbation of chronic condition, or medical history that in the investigator's opinion would interfere with the study
15. Any contraindication for MRI scanning
16. Medication use known to hamper safety during the study procedures
17. Non-German speaking

Where it's running

• German Diabetes Center (DDZ)
  Düsseldorf, Germany Recruiting

Study contacts

• Principal investigator: Patrick Schrauwen, PhD — German Diabetes Center
• Study coordinator: Patrick Schrauwen, PhD
• Email: patrick.schrauwen@ddz.de
• Phone: +49 211 3382-689

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.