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Exercise-mediated Rescue of Mitochondrial Dysfunctions Driving Insulin Resistance

Not Applicable
Recruiting
Conditions
Mitochondrial Disorders
Mitochondrial Myopathies
Mitochondrial Diseases
Interventions
Behavioral: High-intensity exercise training
Registration Number
NCT06080594
Lead Sponsor
Rigshospitalet, Denmark
Brief 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

Detailed Description

Background: Peripheral insulin resistance is a major risk factor for metabolic diseases such as type 2 diabetes. Skeletal muscle accounts for the majority of insulin-stimulated glucose disposal, hence restoring insulin action in skeletal muscle is key in the prevention of type 2 diabetes. Mitochondrial dysfunction is implicated in the etiology of muscle insulin resistance. Also, as mitochondrial function is determined by its proteome quantity and quality, alterations in the muscle mitochondrial proteome may play a critical role in the pathophysiology of insulin resistance. However, insulin resistance is multifactorial in nature and whether mitochondrial derangements are a cause or a consequence of impaired insulin action is unclear. In recent years, the study of humans with genetic mutations has shown enormous potential to establish the mechanistic link between two physiological variables; indeed, if the mutation has a functional impact on one of those variables, then the direction of causality can be readily ascribed. Mitochondrial myopathies are genetic disorders of the mitochondrial respiratory chain affecting predominantly skeletal muscle. Mitochondrial myopathies are caused by pathogenic mutations in either nuclear or mitochondrial DNA (mtDNA), which ultimately lead to mitochondrial dysfunction. Although the prevalence of mtDNA mutations is just 1 in 5,000, the study of patients with mtDNA defects has the potential to provide unique information on the pathogenic role of mitochondrial derangements that is disproportionate to the rarity of affected individuals. The m.3243A\>G mutation in the MT-TL1 gene encoding the mitochondrial leucyl-tRNA 1 gene is the most common mutation leading to mitochondrial myopathy in humans. The m.3243A\>G mutation is associated with impaired glucose tolerance and insulin resistance in skeletal muscle. Most importantly, insulin resistance precedes impairments of β-cell function in carriers of the m.3243A\>G mutation, making these patients an ideal human model to study the causative nexus between muscle mitochondrial dysfunction and insulin resistance. Exercise training is a potent stimulus to enhance muscle insulin action, improve mitochondrial function, and promote mitochondrial proteome remodeling. Accordingly, rescue of mitochondrial dysfunction has been proposed to play a role in the insulin-sensitizing effect of exercise. Yet, numerous mechanisms may contribute to the pathophysiology of insulin resistance and the beneficial effects of exercise may be linked to amelioration of multiple factors, thus challenging the interpretation of the functional significance of improved muscle mitochondrial function per se. Nevertheless, since mitochondrial dysfunction is likely the primary cause of muscle insulin resistance in carriers of the m.3243A\>G mutation, prospective studies including an in-depth analysis of the mitochondrial adaptations elicited by exercise training in this cohort of patients may offer a unique opportunity to identify those mitochondrial derangements that, once rescued, drive enhancements in insulin sensitivity.

Objective: To study the effects of exercise training on muscle insulin sensitivity, muscle mitochondrial function, and the muscle mitochondrial proteome in individuals harboring pathogenic mitochondrial DNA (mtDNA) mutations associated with an insulin-resistant phenotype.

Study design: Within-subject parallel-group longitudinal study in individuals with pathogenic mtDNA mutations undergoing an exercise training intervention with one leg (contralateral leg as inactive control).

Endpoint: Differences between the trained and the untrained leg.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
15
Inclusion Criteria
  • Known m.3243A>G mutation in the MT-TL1 gene encoding the mitochondrial leucyl-tRNA 1 gene
  • Other known mtDNA point mutations
Exclusion Criteria
  • Use of antiarrhythmic medications or other medications which, in the opinion of the investigators, have the potential to affect outcome measures.
  • Diagnosed severe heart disease, dysregulated thyroid gland conditions, or other dysregulated endocrinopathies, or other conditions which, in the opinion of the investigators, have the potential to affect outcome measures.
  • Pregnancy

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Exercise legHigh-intensity exercise trainingHigh-intensity exercise training for one leg
Primary Outcome Measures
NameTimeMethod
Muscle mitochondrial respirationBaseline

Mitochondrial O2 flux is measured by high-resolution respirometry in permeabilized fibers from muscle biopsy samples

Muscle mitochondrial proteomeBaseline

Mitochondrial proteome signatures are determined by mass spectrometry-based proteomics in muscle biopsy samples

Skeletal muscle insulin sensitivity90-150 minutes after initiation of a hyperinsulinemic euglycemic clamp

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

Muscle mitochondrial reactive oxygen species (ROS) productionBaseline

Mitochondrial H2O2 emission rates are measured by high-resolution fluorometry in permeabilized fibers from muscle biopsy samples

Secondary Outcome Measures
NameTimeMethod
Muscle integrated stress response signaling proteinsBaseline

Abundance of (phosphorylated) proteins governing the integrated stress response pathway is measured by immunoblotting in muscle biopsy samples.

Muscle mtDNA heteroplasmyBaseline

mtDNA mutation load is measured in muscle biopsy samples from the patients with mitochondrial myopathy

Muscle integrated stress response genesBaseline

mRNA content of genes governing the integrated stress response pathway is measured by Real-Time PCR in muscle biopsy samples.

Muscle release of FGF21 and GDF15Before (baseline) and 0-150 minutes after initiation of the hyperinsulinemic-euglycemic clamp

Skeletal muscle production of FGF21 and GDF15 is determined by measurements of femoral artery blood flow and arteriovenous difference of plasma FGF21 and GDF15

Muscle insulin signalingBefore (baseline) and 150 minutes after initiation of the hyperinsulinemic-euglycemic clamp

Insulin-mediated changes in the abundance of (phosphorylated) proteins modulating insulin action are measured by immunoblotting in muscle and fat biopsy samples

Whole-body insulin sensitivity90-150 minutes after initiation of a hyperinsulinemic euglycemic clamp

Whole-body insulin sensitivity is determined by the hyperinsulinemic-euglycemic clamp method

Trial Locations

Locations (1)

Rigshospitalet

🇩🇰

Copenhagen, Denmark

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