Timing Exercise Training as Strategy to Improve Insulin Sensitivity and Substrate Metabolism in M… (NCT06014684) | Clinical Trial Compass
CompletedNot Applicable
Timing Exercise Training as Strategy to Improve Insulin Sensitivity and Substrate Metabolism in Men and Woman With Pre-diabetes
Netherlands15 participantsStarted 2023-07-13
Plain-language summary
n a retrospective analysis of an exercise training program performed either in the morning or afternoon, we found that the afternoon training group improved their peripheral insulin sensitivity and fasting plasma glucose levels to a greater extent than the morning group. However, underlying mechanisms are unclear.
The primary study endpoint is nocturnal glucose levels measured by a continuous glucose monitor (CGM).
Who can participate
Age range
40 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hamper…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
nocturnal glucose levels
Timeframe: measured before and after the 12 weeks training program