Investigating the effects of exercise timing on metabolism in prediabetes
Timed Exercise to Acutely Improve Energy and Substrate Metabolism at Night in Men and Women With Prediabetes
This study is testing whether exercising in the morning or late afternoon can help people with prediabetes improve their metabolism and insulin sensitivity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Maastricht University Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT05073068 on ClinicalTrials.gov |
What this trial studies
This study aims to determine how the timing of an acute exercise session, either in the morning or late afternoon, influences nighttime metabolism in individuals with prediabetes. Participants will engage in a glycogen-lowering exercise bout while residing in a respiration chamber, allowing for precise measurement of metabolic responses. The research focuses on understanding the relationship between exercise timing and metabolic health, particularly in improving insulin sensitivity and overall metabolic function. Blood samples will also be collected to analyze circulating metabolites and their response to exercise.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy men and post-menopausal women aged 50 to 75 years with a BMI of 25 kg/m2 or higher and diagnosed with prediabetes.
Not a fit: Patients who have been previously diagnosed with type 2 diabetes or have uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to optimized exercise recommendations that improve metabolic health and reduce the risk of developing type 2 diabetes.
How similar studies have performed: While the specific timing of exercise in relation to metabolism is a relatively novel approach, previous studies have shown that exercise positively impacts metabolic health, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Healthy (determined by dependent physician) * Man or post-menopausal woman * Age between 50 - 75 years * BMI ≥ 25 kg/m2 * Pre-diabetes based on meeting at least one of the following criteria: impaired glucose tolerance defined as plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during oral glucose tolerance test in screening, impaired fasting glucose defined as fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l, insulin resistance defined as a glucose clearance rate ≤ 360 mL/kg/min as determined using OGIS120, HbA1c of 5.7-6.4% * Regular sleeping habits (7 - 9h of daily sleep) * Stable diet and weight: No weight gain or loss \> 3kg in the last three months Exclusion Criteria: * Not meeting all inclusion criteria * Fasting plasma glucose * ≥ 7.0 mmol/L * Hemoglobin \< 7.8 mmol/L * Previously diagnosed with type 2 diabetes * Uncontrolled hypertension * In case of an abnormal electrocardiogram at rest: this will be discussed with the responsible medical doctor * Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed * Any contra-indication to the Equivital telemetric pill * Hypomotility disorders of the gastro-intestinal tract * Extreme early bird or extreme night person (score ≤30 or ≥70 on morning-eveningness questionnaire self assessment) * Heavily varying sleep-wake rhythm * Night shift work during last 3 months * Travel across \> 1 time zone in the last 3 months * Frequent engagement in programmed exercise as judged by the investigator * Significant food allergies/intolerance (seriously hampering study meals) * Participation in another biomedical study within 1 month before the first study visit * Using \> 400mg caffeine daily (more than 4 cups of coffee or energy drinks) * Smoking * Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's opinion interfere with the study * Antecubital veins that present tremendous difficulty in obtaining frequent blood draws (e.g. too small)
Where this trial is running
Maastricht, Limburg
- Maastricht University — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Principal investigator: Joris Hoeks, Dr — Maastricht University
- Study coordinator: Marit Kotte, MSc
- Email: m.kotte@maastrichtuniversity.nl
- Phone: 43 38 85 819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.