NCT04558190

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 22, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

December 2, 2021

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

September 2, 2020

Last Update Submit

December 1, 2021

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (2)

  • Whole body Insulin sensitivity

    Whole body insulin sensitivity is determined by hyperinsulinemic isoglycemic clamp method

    5 hours after lipid infusion

  • 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 Outcomes (5)

  • Mitochondrial respiration

    Baseline

  • Mitochondrial reactive oxygen species

    Baseline

  • Mitochondrial oxidative stress

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

  • Muscle redox status

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

  • Insulin signalling

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

Other Outcomes (2)

  • Cardiorespiratory fitness

    Baseline

  • Body composition

    Baseline

Study Arms (4)

Lipid infusion + MitoQ

EXPERIMENTAL

Subjects undergo a hyperinsulinemic isoglycemic clamp preceded by MitoQ administration and intravenous lipid infusion

Drug: Intralipid, 20% Intravenous EmulsionDietary Supplement: MitoQ

Lipid infusion + placebo

PLACEBO COMPARATOR

Subjects undergo a hyperinsulinemic isoglycemic clamp preceded by placebo administration and intravenous lipid infusion

Drug: Intralipid, 20% Intravenous Emulsion

Control

NO INTERVENTION

Subjects undergo a hyperinsulinemic isoglycemic clamp

Lipid infusion + beta2-agonist

OTHER

Subjects undergo a hyperinsulinemic isoglycemic clamp with intravenous infusion of lipid and salbutamol

Drug: Intralipid, 20% Intravenous EmulsionDrug: Salbutamol

Interventions

Intralipid, 20% Intravenous EmulsionDRUG

Lipid infusion

Lipid infusion + MitoQLipid infusion + beta2-agonistLipid infusion + placebo
MitoQDIETARY_SUPPLEMENT

Oral administration of MitoQ capsules

Also known as: Mitoquinone mesylate, Mitoquinone, MitoQ10
Lipid infusion + MitoQ
SalbutamolDRUG

Beta2-agonist infusion

Lipid infusion + beta2-agonist

Eligibility Criteria

Age40 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

August Krogh Building

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

soybean oil, phospholipid emulsionmitoquinoneAlbuterol

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylamines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 2, 2020

First Posted

September 22, 2020

Study Start

September 2, 2020

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

December 2, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)