Insulin and Muscle Fat Metabolism

NCT04759872 | Terminated

• 1 other identifier: IRB-2020-0768
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Insulin Resistance; Metabolic Disease; Mitochondrial Metabolism; Sedentary Lifestyle

Outcome Measures

Primary Outcomes (1)

• Changes in skeletal muscle lipid content during hyperinsulinemia compared with basal resting conditions

  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 Outcomes (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

Study Arms (1)

Metabolic Study Visit

EXPERIMENTAL

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

Other: Hyperinsulinemic-euglycemic Clamp

Interventions

Hyperinsulinemic-euglycemic Clamp 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).

Metabolic Study Visit

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon State University: lead

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Insulin Resistance; Metabolic Diseases; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Behavior

Study Officials

• Sean A Newsom, Ph.D.

  Oregon State University

  PRINCIPAL INVESTIGATOR

• Matthew M Robinson, Ph.D.

  Oregon State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 18, 2021
• Study Start: February 22, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: June 10, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)