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

NCT06014684 | Completed DMC

• 1 other identifier: NL83421.068.22
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Pre-diabetes; Overweight and Obesity

Outcome Measures

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.

  measured before and after the 12 weeks training program

Secondary Outcomes (2)

• 24h whole body energy expenditure

  measured before and after the 12 weeks training program

• 24h substrate metabolism

  measured before and after the 12 weeks training program

Other Outcomes (8)

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

  measured before and after the 12 weeks training program

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

  measured before and after the 12 weeks training program

• Intrahepatic lipid content and composition

  measured before and after the 12 weeks training program

Study Arms (2)

AM exercise

EXPERIMENTAL

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

Behavioral: Timing of exercise

PM exercise

EXPERIMENTAL

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

Behavioral: Timing of exercise

Interventions

Timing of exercise BEHAVIORAL

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

AM exercise; PM exercise

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229 ER, Netherlands

Location

MeSH Terms

Conditions

Glucose Intolerance; Overweight; Obesity

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 28, 2023
• Study Start: July 13, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

NL (1)