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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06080594
Other study ID # EX-MITO-DYS-IR
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date December 2025

Study information

Verified date March 2024
Source Rigshospitalet, Denmark
Contact Matteo Fiorenza, Ph.D.
Phone +4535458748
Email matteo.fiorenza@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overarching aim of this intervention study is to interrogate the interconnection between the muscle mitochondrial adaptations and the changes in muscle insulin sensitivity elicited by exercise training in individuals harbouring pathogenic mitochondrial DNA mutations associated with an insulin-resistant phenotype. In a within-subject parallel-group longitudinal design, participants will undergo an exercise training intervention with one leg, while the contralateral leg will serve as an inactive control. After the exercise intervention, patients will attend an experimental trial including: - A hyperinsulinemic-euglycemic clamp combined with measurements of femoral artery blood flow and arteriovenous difference of glucose - Muscle biopsy samples


Description:

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Study Design


Intervention

Behavioral:
High-intensity exercise training
Eight sessions of high-intensity knee extensor exercise are conducted on separate days over a 2-week period.

Locations

Country Name City State
Denmark Rigshospitalet Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (17)

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Outcome

Type Measure Description Time frame Safety issue
Other Leg muscle mass Leg muscle mass is determined by dual-energy X-ray absorptiometry Baseline
Primary Skeletal muscle insulin sensitivity Insulin-stimulated muscle glucose uptake is determined by the hyperinsulinemic-euglycemic clamp method integrated with measurements of femoral artery blood flow and arteriovenous difference of glucose 90-150 minutes after initiation of a hyperinsulinemic euglycemic clamp
Primary Muscle mitochondrial respiration Mitochondrial O2 flux is measured by high-resolution respirometry in permeabilized fibers from muscle biopsy samples Baseline
Primary Muscle mitochondrial reactive oxygen species (ROS) production Mitochondrial H2O2 emission rates are measured by high-resolution fluorometry in permeabilized fibers from muscle biopsy samples Baseline
Primary Muscle mitochondrial proteome Mitochondrial proteome signatures are determined by mass spectrometry-based proteomics in muscle biopsy samples Baseline
Secondary Muscle mtDNA heteroplasmy mtDNA mutation load is measured in muscle biopsy samples from the patients with mitochondrial myopathy Baseline
Secondary Muscle insulin signaling Insulin-mediated changes in the abundance of (phosphorylated) proteins modulating insulin action are measured by immunoblotting in muscle and fat biopsy samples Before (baseline) and 150 minutes after initiation of the hyperinsulinemic-euglycemic clamp
Secondary Muscle integrated stress response signaling proteins Abundance of (phosphorylated) proteins governing the integrated stress response pathway is measured by immunoblotting in muscle biopsy samples. Baseline
Secondary Muscle integrated stress response genes mRNA content of genes governing the integrated stress response pathway is measured by Real-Time PCR in muscle biopsy samples. Baseline
Secondary Muscle release of FGF21 and GDF15 Skeletal muscle production of FGF21 and GDF15 is determined by measurements of femoral artery blood flow and arteriovenous difference of plasma FGF21 and GDF15 Before (baseline) and 0-150 minutes after initiation of the hyperinsulinemic-euglycemic clamp
Secondary Whole-body insulin sensitivity Whole-body insulin sensitivity is determined by the hyperinsulinemic-euglycemic clamp method 90-150 minutes after initiation of a hyperinsulinemic euglycemic clamp
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