Mitochondrial Dysfunction and Insulin Resistance in Skeletal Muscle

NCT ID: NCT04558190

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-02

Study Completion Date

2021-11-01

Brief Summary

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

Detailed Description

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Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lipid infusion + MitoQ

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

Group Type EXPERIMENTAL

Intralipid, 20% Intravenous Emulsion

Intervention Type DRUG

Lipid infusion

MitoQ

Intervention Type DIETARY_SUPPLEMENT

Oral administration of MitoQ capsules

Lipid infusion + placebo

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

Group Type PLACEBO_COMPARATOR

Intralipid, 20% Intravenous Emulsion

Intervention Type DRUG

Lipid infusion

Control

Subjects undergo a hyperinsulinemic isoglycemic clamp

Group Type NO_INTERVENTION

No interventions assigned to this group

Lipid infusion + beta2-agonist

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

Group Type OTHER

Intralipid, 20% Intravenous Emulsion

Intervention Type DRUG

Lipid infusion

Salbutamol

Intervention Type DRUG

Beta2-agonist infusion

Interventions

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Intralipid, 20% Intravenous Emulsion

Lipid infusion

Intervention Type DRUG

MitoQ

Oral administration of MitoQ capsules

Intervention Type DIETARY_SUPPLEMENT

Salbutamol

Beta2-agonist infusion

Intervention Type DRUG

Other Intervention Names

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Mitoquinone mesylate Mitoquinone MitoQ10

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Morten Hostrup, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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August Krogh Building

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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mtROS-IR

Identifier Type: -

Identifier Source: org_study_id