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Insulin and Muscle Fat Metabolism

Sponsor
Oregon State University (Other)
Overall Status
Terminated
CT.gov ID
NCT04759872
Collaborator
(none)
9
Enrollment
1
Location
1
Arm
15.4
Actual Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Hyperinsulinemic-euglycemic Clamp
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Insulin and Muscle Fat Metabolism
Actual Study Start Date :
Feb 22, 2021
Actual Primary Completion Date :
Jun 7, 2022
Actual Study Completion Date :
Jun 7, 2022

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Changes in skeletal muscle lipid content during hyperinsulinemia compared with basal resting conditions [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.

Secondary Outcome Measures

  1. Changes in skeletal muscle mitochondrial oxidative capacity during hyperinsulinemia compared with basal resting conditions [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oregon State University Corvallis Oregon United States 97331

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sean Newsom, Associate Professor, Oregon State University
ClinicalTrials.gov Identifier:
NCT04759872
Other Study ID Numbers:
  • IRB-2020-0768
First Posted:
Feb 18, 2021
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Insulin Resistance
Metabolic Diseases
Overweight

Study Results

No Results Posted as of Jun 10, 2022