Clinical Trials Directory

Trials / Completed

CompletedNCT04565418

Exercise to Restore 24h Rhythms in Metabolism

Exercise to Restore 24h Rhythmicity in Substrate Metabolism of Prediabetes Subjects

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Maastricht University · Academic / Other
Sex
Male
Age
40 Years – 75 Years
Healthy volunteers
Accepted

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.

Detailed description

Recent evidence shows that pre-diabetes is characterized by marked alterations in 24h substrate metabolism, indicating metabolic inflexibility with an inability to fully switch to fat oxidation during the night. Whereas exercise has been shown to promote mitochondrial function and insulin sensitivity, it is unknown to if exercise training is able to restore 24h rhythmicity in overall substrate metabolism and muscle metabolism in human subjects with pre-diabetes. In this single-arm longitudinal design, subjects will serve as their own control. Subjects will perform high-intensity interval training for 12 weeks (3x times per week) on a cycle ergometer at the research facility. Pre and post exercise, subjects will stay in a metabolic chamber and adhere to a relatively normal life-style in order to standardize the main 24h measurement period. As the primary outcome, substrate metabolism will be measured with a ventilated hood system and by indirect calorimetry in the chambers. Muscle biopsies from the vastus lateralis and frequent blood samples will also be taken over the course of the 24h. Thereby, ex-vivo skeletal muscle mitochondrial function and muscle clock gene expression will serve as the main secondary outcomes.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHigh-intensity interval training3 times per week high-intensity interval training (HIIT) will be performed on a cycle ergometer for 12 weeks adding up to 36 HIIT sessions

Timeline

Start date
2021-01-26
Primary completion
2022-12-22
Completion
2023-04-24
First posted
2020-09-25
Last updated
2023-05-24

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT04565418. Inclusion in this directory is not an endorsement.