Insulin and Muscle Fat Metabolism

June 7, 2022 updated by: Sean Newsom, Oregon State University
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Corvallis, Oregon, United States, 97331
        • Oregon State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metabolic Study Visit
Participants will complete a study visit for metabolic phenotyping and determination of the impact of hyperinsulinemia on outcomes of interest.
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in skeletal muscle lipid content during hyperinsulinemia compared with basal resting conditions
Time Frame: Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit
Liquid chromatography tandem mass spectrometry (targeted lipidomics) will be used to assess species-level changes in skeletal muscle lipid content in biopsy samples collected before and after the insulin infusion to induce mild hyperinsulinemia.
Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in skeletal muscle mitochondrial oxidative capacity during hyperinsulinemia compared with basal resting conditions
Time Frame: Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit
High-resolution respirometry will be used to assess changes in skeletal muscle mitochondrial oxidative capacity in biopsy samples collected before and after the insulin infusion to induce mild hyperinsulinemia.
Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon State University

Investigators

  • Principal Investigator: Sean A Newsom, Ph.D., Oregon State University
  • Principal Investigator: Matthew M Robinson, Ph.D., Oregon State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Actual)

June 7, 2022

Study Completion (Actual)

June 7, 2022

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 7, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-2020-0768

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sedentary Lifestyle

Clinical Trials on Hyperinsulinemic-euglycemic Clamp

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe