Exercise timing to improve insulin sensitivity in pre-diabetic individuals
Timing Exercise Training as Strategy to Improve Insulin Sensitivity and Substrate Metabolism in Men and Woman With Pre-diabetes
This study is testing if exercising in the afternoon helps people with pre-diabetes improve their insulin sensitivity better than exercising in the morning.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht, Limburg) |
| Trial ID | NCT06014684 on ClinicalTrials.gov |
What this trial studies
This study investigates whether exercising in the afternoon is more effective than morning exercise for improving insulin sensitivity in individuals with pre-diabetes. It is a randomized double-arm longitudinal intervention involving 24 participants, aged 40-75, who will be assigned to either morning or afternoon exercise sessions. The study aims to explore the underlying mechanisms of how exercise timing affects metabolic processes in pre-diabetic individuals. The findings could provide insights into optimizing exercise regimens for better health outcomes.
Who should consider this trial
Good fit: Ideal candidates are men and postmenopausal women aged 40-75 with a BMI of 25-38 kg/m2 and diagnosed with pre-diabetes.
Not a fit: Patients with type 2 diabetes, severe health conditions, or those who do not meet the inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to tailored exercise recommendations that significantly improve insulin sensitivity and metabolic health in pre-diabetic patients.
How similar studies have performed: Previous studies have indicated that exercise timing can influence metabolic outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 40-75 years. * Body mass index (BMI) ≥25 kg/m2 * Male, or postmenopausal (at least 1 year post cessation of menses) female * Pre-diabetes based on one or a combination of the following criteria: * Impaired Glucose Tolerance (IGT): plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during OGTT in screening * ImpairedFastingGlucose(IFG):Fastingplasmaglucose≥6.1mmol/land≤6.9 mmol/l * Insulin Resistance: glucose clearance rate ≤ 360 mL/kg/min, as determined during the OGTT using OGIS120. * HbA1cof5.7-6.4% Exclusion Criteria: * Type 2 diabetes * Patients with active congestive heart failure and and/or severe renal and or liver insufficiency * Uncontrolled hypertension * Any contra-indication for MRI scanning * Alcohol consumption of \>3 servings per day for man and \>2 servings per day for woman * Smoking * Unstable body weight (weight gain or loss \> 5kg in the last 3 months) * Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator which would possibly hamper our study results. * Medication use known to hamper subject's safety during the study procedures. * Subjects who do not want to be informed about unexpected medical findings. * Men: Hb \<8.0 mmol/L, Women: Hb \<7.0 mmol/l * Heavily varying sleep-wake rhythm (i.e. night shift work and travels across time zones). * Significant food allergies/intolerance (seriously hampering study meals) * Blood donation during or within 2 months prior to the study
Where this trial is running
Maastricht, Limburg
- Maastricht University — Maastricht, Limburg, Netherlands (Recruiting)
Study contacts
- Study coordinator: Ivo Habets, MSc
- Email: i.habets@maastrichtuniversity.nl
- Phone: +31 88 388 7287
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.