Insulin ResistanceNCT04558190
Mitochondrial Dysfunction and Insulin Resistance in Skeletal Muscle
A study testing Intralipid, 20% Intravenous Emulsion, MitoQ and Salbutamol in people with Insulin Resistance, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the study is to evaluate the link between insulin resistance and alterations in skeletal muscle mitochondrial redox homeostasis Read more about this study
- Who is it for?
- Ages 40 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Intralipid, 20% Intravenous Emulsion, MitoQ and Salbutamol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Sep 2020to 1 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to evaluate the link between insulin resistance and alterations in skeletal muscle mitochondrial redox homeostasis
- Conditions
- Insulin Resistance
- Being tested
- Intralipid, 20% Intravenous Emulsion, MitoQ, Salbutamol
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralipid, 20% Intravenous EmulsionDrug
Lipid infusion
MitoQDietary supplement
Also called Mitoquinone mesylate, Mitoquinone, MitoQ10
Oral administration of MitoQ capsules
SalbutamolDrug
Beta2-agonist infusion
| Study group | Role | What they receive |
|---|---|---|
| Lipid infusion + MitoQ | Experimental | Subjects undergo a hyperinsulinemic isoglycemic clamp preceded by MitoQ administration and intravenous lipid infusion Receives: Drug: Intralipid, 20% Intravenous Emulsion; Dietary Supplement: MitoQ |
| Lipid infusion + placebo | Placebo comparator | Subjects undergo a hyperinsulinemic isoglycemic clamp preceded by placebo administration and intravenous lipid infusion Receives: 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 Receives: Drug: Intralipid, 20% Intravenous Emulsion; Drug: Salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body Insulin sensitivity
Whole body insulin sensitivity is determined by hyperinsulinemic isoglycemic clamp method
Measured: 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
Measured: 5 hours after lipid infusion
Secondary outcomes (5)
Mitochondrial respiration
Mitochondrial O2 flux is determined in skeletal muscle biopsies by high-resolution fluorespirometry
Measured: Baseline
Mitochondrial reactive oxygen species
Mitochondrial H2O2 emission rate is determined in skeletal muscle biopsies by high-resolution fluorespirometry
Measured: Baseline
Mitochondrial oxidative stress
Peroxiredoxin3 dimer/monomer ratio is determined in skeletal muscle biopsies
Measured: Before (baseline) as well as 3 and 5 hours after lipid infusion
Muscle redox status
GSH/GSSG ratio is determined in skeletal muscle biopsies
Measured: Before (baseline) as well as 3 and 5 hours after lipid infusion
Insulin signalling
Phosphorylation status of proteins modulating insulin action is determined in skeletal muscle biopsies
Measured: Before (baseline) as well as 3 and 5 hours after lipid infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start2 Sep 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Hostrup, PhD, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558190
- Sponsor's protocol ID
- mtROS-IR
- Status last verified
- Dec 2021
- First submitted
- 2 Sep 2020
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitochondrial Dysfunction and Insulin Resistance in Skeletal Muscle
- ClinicalTrials.gov ID
- NCT04558190
- Acronym / sponsor ID
- mtROS-IR
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the link between insulin resistance and alterations in skeletal muscle mitochondrial redox homeostasis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lipid infusion + MitoQ | Experimental | Drug: Intralipid, 20% Intravenous Emulsion, Dietary Supplement: MitoQSubjects undergo a hyperinsulinemic isoglycemic clamp preceded by MitoQ administration and intravenous lipid infusion |
| Lipid infusion + placebo | Placebo comparator | Drug: Intralipid, 20% Intravenous EmulsionSubjects undergo a hyperinsulinemic isoglycemic clamp preceded by placebo administration and intravenous lipid infusion |
| Control | No intervention | –Subjects undergo a hyperinsulinemic isoglycemic clamp |
| Lipid infusion + beta2-agonist | Other | Drug: Intralipid, 20% Intravenous Emulsion, Drug: SalbutamolSubjects undergo a hyperinsulinemic isoglycemic clamp with intravenous infusion of lipid and salbutamol |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralipid, 20% Intravenous EmulsionLipid infusion | Drug | Lipid infusion + MitoQ, Lipid infusion + beta2-agonist, Lipid infusion + placebo |
| MitoQAlso: Mitoquinone mesylate, Mitoquinone, MitoQ10Oral administration of MitoQ capsules | Dietary supplement | Lipid infusion + MitoQ |
| SalbutamolBeta2-agonist infusion | Drug | Lipid infusion + beta2-agonist |
Primary outcome
Whole body Insulin sensitivity
Time frame: 5 hours after lipid infusion
Whole body insulin sensitivity is determined by hyperinsulinemic isoglycemic clamp method
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
5 secondary outcomes
Mitochondrial respiration
Time frame: Baseline
Mitochondrial reactive oxygen species
Time frame: Baseline
Mitochondrial oxidative stress
Time frame: Before (baseline) as well as 3 and 5 hours after lipid infusion
Muscle redox status
Time frame: Before (baseline) as well as 3 and 5 hours after lipid infusion
Insulin signalling
Time frame: Before (baseline) as well as 3 and 5 hours after lipid infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2021.
- Individual participant dataSharing planned: No
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Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intralipid, 20% Intravenous Emulsion, MitoQ and Salbutamol in people with Insulin Resistance, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body Insulin sensitivity (time frame: 5 hours after lipid infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2021.