Status:
RECRUITING
Timing Exercise Training as Strategy to Improve Insulin Sensitivity and Substrate Metabolism in Men and Woman With Pre-diabetes
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Pre-diabetes
Overweight and Obesity
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief 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 fa...
Detailed Description
Rationale: Various metabolic processes, including resting metabolic rate, insulin sensitivity and insulin secretion, follow a recurring 24-hour cycle. These rhythms are shown to be disturbed in in pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06014684
Start Date
July 13 2023
End Date
March 31 2026
Last Update
September 30 2025
Active Locations (1)
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1
Maastricht University
Maastricht, Limburg, Netherlands, 6229 ER