Insulin and Muscle Fat Metabolism

NCT ID: NCT04759872

Last Updated: 2022-06-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2022-06-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Our objective in this study is to identify the extent to which insulin drives the accumulation of lipids in skeletal muscle of humans. We will test the hypothesis that 4-hours of mild hyperinsulinemia will result in significant muscle lipid accumulation and that such effects will be similar in lean and overweight/obese humans.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Overweight and Obesity Insulin Resistance Metabolic Disease Mitochondrial Metabolism Sedentary Lifestyle

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants will be asked to complete 1 screening visit to determine eligibility.

If participants remain eligible, they will be asked to complete 1 metabolic study visit.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Metabolic Study Visit

Participants will complete a study visit for metabolic phenotyping and determination of the impact of hyperinsulinemia on outcomes of interest.

Group Type EXPERIMENTAL

Hyperinsulinemic-euglycemic Clamp

Intervention Type OTHER

Participants will be administered a constant-rate insulin infusion (to induce mild hyperinsulinemia), with an infusion of dextrose to maintain blood glucose concentration (to maintain euglycemia).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hyperinsulinemic-euglycemic Clamp

Participants will be administered a constant-rate insulin infusion (to induce mild hyperinsulinemia), with an infusion of dextrose to maintain blood glucose concentration (to maintain euglycemia).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 30-55 years
* Body mass index (BMI) 18-45 kg/m2
* Sedentary (\<1 hour of planned exercise per week)

Exclusion Criteria

* Regular exercise (\>1 hour of planned exercise per week)
* Smoking, tobacco or nicotine use within the last 1-year
* Fasting glucose \>126mg/dL
* Hypertension (systolic pressure \>140 mmHg or diastolic pressure \>90 mmHg)
* Chronic metabolic or cardiovascular health conditions
* Pregnant, nursing, irregular menses or post-menopausal
* Lidocaine allergy
* Certain medications
* Diminished capacity for consent
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oregon State University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sean Newsom

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sean A Newsom, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Matthew M Robinson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oregon State University

Corvallis, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-2020-0768

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Role of Metformin on Muscle Health of Older Adults
NCT03107884 ACTIVE_NOT_RECRUITING EARLY_PHASE1
Investigating Muscle Failure in Diabetic Myopathy
NCT05685927 ACTIVE_NOT_RECRUITING
Lipids and Insulin Sensitivity
NCT01466816 COMPLETED NA