RecruitingNot ApplicableNCT06014684

Timing Exercise Training as Strategy to Improve Insulin Sensitivity and Substrate Metabolism in Men and Woman With Pre-diabetes


Sponsor

Maastricht University Medical Center

Enrollment

24 participants

Start Date

Jul 13, 2023

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria8

  • 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 Criteria14

  • 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

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Interventions

BEHAVIORALTiming of exercise

High Intensity Interval Training (HIIT) program for 12 weeks (3 per week/36 sessions in total)


Locations(1)

Maastricht University

Maastricht, Limburg, Netherlands

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NCT06014684


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