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OpenTrials
Completed

NCT Number: NCT04558190

Mitochondrial Dysfunction and Insulin Resistance in Skeletal Muscle

The purpose of the study is to evaluate the link between insulin resistance and alterations in skeletal muscle mitochondrial redox homeostasis

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Key information

Conditions

Insulin Resistance Glucose Metabolism Disorders Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

August Krogh Building

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI) ≥25 and <40 kg/m2
  • Fasting plasma glucose ≥ 5.6 mmol/L or HbA1c ≥ 5.7%
  • HOMA2-IR > 1.4
  • VO2max <45 ml/kg/min

Exclusion criteria

  • Treatment with >2 antidiabetic medications
  • Insulin usage
  • Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
  • Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
  • Smoking

Treatment and study plan

Intralipid, 20% Intravenous Emulsion

Drug

Lipid infusion

MitoQ

Dietary Supplement

Oral administration of MitoQ capsules

Other names: Mitoquinone mesylate, Mitoquinone, MitoQ10

Salbutamol

Drug

Beta2-agonist infusion

Primary outcomes

  1. Whole body Insulin sensitivity

    Time frame: 5 hours after lipid infusion

    Whole body insulin sensitivity is determined by hyperinsulinemic isoglycemic clamp method

  2. Skeletal muscle insulin sensitivity

    Time frame: 5 hours after lipid infusion

    Insulin-dependent skeletal muscle glucose uptake is determined by hyperinsulinemic isoglycemic clamp method integrated with measurements of femoral artery blood flow and arteriovenous difference of glucose

Secondary outcomes

  1. Mitochondrial respiration

    Time frame: Baseline

    Mitochondrial O2 flux is determined in skeletal muscle biopsies by high-resolution fluorespirometry

  2. Mitochondrial reactive oxygen species

    Time frame: Baseline

    Mitochondrial H2O2 emission rate is determined in skeletal muscle biopsies by high-resolution fluorespirometry

  3. Mitochondrial oxidative stress

    Time frame: Before (baseline) as well as 3 and 5 hours after lipid infusion

    Peroxiredoxin3 dimer/monomer ratio is determined in skeletal muscle biopsies

  4. Muscle redox status

    Time frame: Before (baseline) as well as 3 and 5 hours after lipid infusion

    GSH/GSSG ratio is determined in skeletal muscle biopsies

  5. Insulin signalling

    Time frame: Before (baseline) as well as 3 and 5 hours after lipid infusion

    Phosphorylation status of proteins modulating insulin action is determined in skeletal muscle biopsies

Other outcomes

  1. Cardiorespiratory fitness

    Time frame: Baseline

    Pulmonary maximal oxygen uptake (VO2max) is determined during an incremental exercise test to exhaustion

  2. Body composition

    Time frame: Baseline

    Fat free mass and fat mass are determined by dual-energy X-ray absorptiometry (DXA)

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 22, 2020
Registry last updated
Dec 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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