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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04558190
Other study ID # mtROS-IR
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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