Exercise to Restore 24h Rhythms in Metabolism

NCT04565418 | Completed DMC

• 1 other identifier: NL73834.068.20
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the effect of exercise training on 24h rhythms in substrate metabolism in overweight subjects with impaired glucose tolerance. Subjects will perform exercise training for 12 weeks. Before and after the exercise period, they will be admitted to research facilities for 45 hours to assess 24h rhythms in substrate metabolism. In a single-arm longitudinal design, subjects will serve as their own control.

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Keywords

Circadian rhythm

Outcome Measures

Primary Outcomes (3)

• Change in 24 rhythm in whole-body energy metabolism (energy expenditure)

  Energy expenditure (kJ/min) measured by indirect calorimetry

  measured at 8:00, 13:00, 18:00, 23:00, 04:00 of the main test day before and after 12 weeks of exerise

• Change in 24 rhythm in whole-body energy metabolism (glucose oxidation)

  Energy expenditure (kJ/min) measured by indirect calorimetry

  measured at 8:00, 13:00, 18:00, 23:00, 04:00 of the main test day before and after 12 weeks of exercise

• Change in 24 rhythm in whole-body energy metabolism (fat oxidation)

  Energy expenditure (kJ/min) measured by indirect calorimetry

  measured at 8:00, 13:00, 18:00, 23:00, 04:00 of the main test day before and after 12 weeks of exercise

Secondary Outcomes (13)

• Change in 24 rhythm in skeletal muscle mitochondrial respiration

  measured at 8:00, 13:00, 23:00 of the main test day before and after 12 weeks of exercise

• Change in 24h rhythm in muscle protein levels of markers involved in molecular clock and mitochondrial metabolism

  measured at 8:00, 13:00, 23:00 of the main test day before and after 12 weeks of exercise

• Change in 24h rhythm in muscle DNA of markers involved in molecular clock and mitochondrial metabolism

  measured at 8:00, 13:00, 23:00 of the main test day before and after 12 weeks of exercise

• Change in 24h rhythm in muscle DNA involved in molecular clock and mitochondrial metabolism.

  measured at 8:00, 13:00, 23:00 of the main test day before and after 12 weeks of exercise

• Change in 24h rhythm in muscle mRNA markers involved in molecular clock and mitochondrial metabolism

  measured at 8:00, 13:00, 23:00 of the main test day before and after 12 weeks of exercise

Study Arms (1)

Exercise training

EXPERIMENTAL

12 week high-intensity interval training (3 sessions per week): Before and after exercise, subjects are kept at the research facility to adhere to a standardized living protocol, mimicking a normal daily living situation. During the study, multiple tests will be performed, including muscle biopsies, blood draws and indirect calorimetry.

Behavioral: High-intensity interval training

Interventions

High-intensity interval training BEHAVIORAL

3 times per week high-intensity interval training (HIIT) will be performed on a cycle ergometer for 12 weeks adding up to 36 HIIT sessions

Exercise training

Eligibility Criteria

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

You may qualify if:

• Caucasian
• Healthy (as determined by dependent physician)
• Overweight: BMI 25 - 35 kg/m2
• Prediabetic 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.
• Impaired Fasting Glucose (IFG): Fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l.
• Insulin Resistance: glucose clearance rate ≤ 360ml/kg/min, as determined using the OGIS120 model.
• HbA1c of 5.7-6.4%.
• Regular sleeping time (normally 7 - 9h daily)
• Stable dietary habits: no weight gain or loss \> 3kg in the last three months.

You may not qualify if:

• Use of anticoagulants
• Previously diagnosed with type 2 diabetes
• Current alcohol consumption \> 20 grams alcohol/day
• Extreme early bird or extreme night person (score ≤ 30 or ≥ 70 on MEQ-SA questionnaire)
• Heavily varying sleep-wake rhythm
• Nightshift work during last 3 months
• Travel across \> 1 time zone in the last 3 months
• Significant food allergies/intolerance (seriously hampering study meals)
• Using \> 400mg caffeine daily (more than 4 coffee or energy drink)
• Smoking

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: September 25, 2020
• Study Start: January 26, 2021
• Primary Completion: December 22, 2022
• Study Completion: April 24, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

NL (1)