Mitochondrial Dysfunction and Insulin Resistance in Skeletal Muscle

Insulin Resistance Clinical Trial

Official title:

Mitochondrial Dysfunction and Insulin Resistance in Skeletal Muscle

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558190
• Other study ID #: mtROS-IR
• Status: Completed
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: December 2021
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Drug:
• Intralipid, 20% Intravenous Emulsion
Lipid infusion

Dietary Supplement:
• MitoQ
Oral administration of MitoQ capsules

Drug:
• Salbutamol
Beta2-agonist infusion

Locations

Country	Name	City	State
Denmark	August Krogh Building	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiorespiratory fitness	Pulmonary maximal oxygen uptake (VO2max) is determined during an incremental exercise test to exhaustion	Baseline
Other	Body composition	Fat free mass and fat mass are determined by dual-energy X-ray absorptiometry (DXA)	Baseline
Primary	Whole body Insulin sensitivity	Whole body insulin sensitivity is determined by hyperinsulinemic isoglycemic clamp method	5 hours after lipid infusion
Primary	Skeletal muscle insulin sensitivity	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	5 hours after lipid infusion
Secondary	Mitochondrial respiration	Mitochondrial O2 flux is determined in skeletal muscle biopsies by high-resolution fluorespirometry	Baseline
Secondary	Mitochondrial reactive oxygen species	Mitochondrial H2O2 emission rate is determined in skeletal muscle biopsies by high-resolution fluorespirometry	Baseline
Secondary	Mitochondrial oxidative stress	Peroxiredoxin3 dimer/monomer ratio is determined in skeletal muscle biopsies	Before (baseline) as well as 3 and 5 hours after lipid infusion
Secondary	Muscle redox status	GSH/GSSG ratio is determined in skeletal muscle biopsies	Before (baseline) as well as 3 and 5 hours after lipid infusion
Secondary	Insulin signalling	Phosphorylation status of proteins modulating insulin action is determined in skeletal muscle biopsies	Before (baseline) as well as 3 and 5 hours after lipid infusion