Insulin and Muscle Fat Metabolism

Insulin Resistance Clinical Trial

Official title:

Insulin and Muscle Fat Metabolism

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04759872
• Other study ID #: IRB-2020-0768
• Status: Terminated
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: June 2022
• Source: Oregon State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Insulin Resistance
• Metabolic Disease
• Metabolic Diseases
• Mitochondrial Metabolism
• Overweight
• Overweight and Obesity
• Sedentary Lifestyle

Intervention

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).

Locations

Country	Name	City	State
United States	Oregon State University	Corvallis	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in skeletal muscle mitochondrial oxidative capacity during hyperinsulinemia compared with basal resting conditions	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