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CompletedNCT06014684Timed TrainingUpdated Apr 17, 2026

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

An interventional study of Timing of exercise in Pre-diabetes and Overweight and Obesity, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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).

Read the 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-diabetes volunteers compared to young healthy volunteers. In 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.

Objective: The main objective of this study is to determine whether prolonged exercise training in the afternoon (15:00-17:00 PM) differs from exercise training in the morning (07:00-09:00 AM) in improving insulin sensitivity in individuals with pre-diabetes, and to investigate its underlying mechanisms.

Study design: The present study is a randomized double arm longitudinal intervention study in a pre and post design.

Study population: 24 pre-diabetic individuals (men and postmenopausal women aged 40 - 75 years and with BMI ≥ 25 and ≤ 38 kg/m2) will complete this study (12 participants in the morning training group and 12 participants in the afternoon training group). From experience with similar studies, we estimate a drop-out rate of 20% and a screening failure of 70% (because individuals often do not know they are pre-diabetic). This results in maximally 30 participants that have to be included and 100 participants that have to be screened (maximally).

Intervention (if applicable): Participants will perform a 12-weeks supervised high intensity interval training (HIIT) program with three \~30 min exercise sessions per week. Participants will be randomly assigned to the morning or afternoon training time. To assess the outcomes, participants will come to the university for a 43h measurement period both before and after the 12-week training program.

Main study parameters/endpoints: The primary study endpoint is nocturnal glucose levels measured by a continuous glucose monitor (CGM). The secondary outcomes are 24h energy and substrate metabolism. Exploratory outcomes are body composition, intrahepatic lipid content and composition, hepatic insulin sensitivity, hepatic glycogen levels, maximal aerobic capacity, skeletal muscle oxidative capacity, visceral and subcutaneous adipose tissue volume, sleeping metabolic rate, blood glucose levels (continuously measured over 7days) and immune responses.

02

Conditions studied

  • Pre-diabetes
  • Overweight and Obesity
03

In context

Glucose Intolerance

778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.

This study's enrollment of 15 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.

Browse Glucose Intolerance studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    AM exercise

    HIIT program performed between 07:00-09:00 AM

    Behavioral: Timing of exercise

  • Experimental
    PM exercise

    HIIT program performed between 15:00-17:00 PM

    Behavioral: Timing of exercise

Interventions

  • BehavioralTiming of exercise

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

06

What researchers measure

Primary outcomes

  1. nocturnal glucose levels

    The main objective of this study is to determine whether prolonged exercise training in the afternoon differs from exercise training in the morning in improving nocturnal glucose levels insulin sensitivity in individuals with pre-diabetes.

    Time frame: measured before and after the 12 weeks training program

Secondary outcomes

  1. 24h whole body energy expenditure

    energy expenditure as measured by a 24h stay in the respiration chamber

    Time frame: measured before and after the 12 weeks training program

  2. 24h substrate metabolism

    24h substrate metabolism as measured by a 24h stay in the respiration chamber

    Time frame: measured before and after the 12 weeks training program

Other outcomes

  1. Body composition by Dual Energy X-ray Absorptiometry (DEXA)

    fat-free mass (kg and percentage)

    Time frame: measured before and after the 12 weeks training program

  2. Body composition by Dual Energy X-ray Absorptiometry (DEXA)

    fat mass (kg and percentage)

    Time frame: measured before and after the 12 weeks training program

  3. Intrahepatic lipid content and composition

    Time frame: measured before and after the 12 weeks training program

  4. Hepatic glycogen levels

    Time frame: measured before and after the 12 weeks training program

  5. VO2 max cycling test

    measurement of participants' maximal aerobic capacity, absolute (L/min) and relative (ml/min/kg)

    Time frame: measured before and after the 12 weeks training program

  6. Skeletal muscle oxidative capacity

    Ex vivo high-resolution respirometry using a two chamber Oxygraph (OROBOROS Instruments) will be performed. Multiple substrate/inhibitor titration protocols will be applied to extensively characterize the mitochondrial capacity of skeletal muscle fibers

    Time frame: measured before and after the 12 weeks training program

  7. Sleeping metabolic rate

    Time frame: measured before and after the 12 weeks training program

  8. Blood glucose levels measured continuously over 7 days.

    Time frame: measured before and at the end the 12 weeks training program

07

Study locations

1 site
  • Maastricht University
    Maastricht, Limburg 6229 ER, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06014684
Lead sponsor
Maastricht University Medical Center
Responsible party
Sponsor
First posted
Aug 28, 2023
Start date
Jul 13, 2023
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026
Last update
Apr 17, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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