Back to resultsInsulin and Muscle Fat Metabolism
Primary Purpose
Overweight and Obesity, Insulin Resistance, Metabolic Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperinsulinemic-euglycemic Clamp
Sponsored by
About this trial
This is an interventional basic science trial for Overweight and Obesity
Eligibility Criteria
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
Sites / Locations
- Oregon State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metabolic Study Visit
Arm Description
Participants will complete a study visit for metabolic phenotyping and determination of the impact of hyperinsulinemia on outcomes of interest.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04759872
Brief Title
Insulin and Muscle Fat Metabolism
Official Title
Insulin and Muscle Fat Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Unsuccessful enrollment during COVID-19 pandemic.
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Insulin Resistance, Metabolic Disease, Mitochondrial Metabolism, Sedentary Lifestyle
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metabolic Study Visit
Arm Type
Experimental
Arm Description
Participants will complete a study visit for metabolic phenotyping and determination of the impact of hyperinsulinemia on outcomes of interest.
Intervention Type
Other
Intervention Name(s)
Hyperinsulinemic-euglycemic Clamp
Intervention Description
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).
Primary Outcome Measure Information:
Title
Changes in skeletal muscle lipid content during hyperinsulinemia compared with basal resting conditions
Description
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.
Time Frame
Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit
Secondary Outcome Measure Information:
Title
Changes in skeletal muscle mitochondrial oxidative capacity during hyperinsulinemia compared with basal resting conditions
Description
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.
Time Frame
Muscle samples will be collected in basal and hyperinsulinemic conditions separated by ~4.5 hours during the metabolic study visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean A Newsom, Ph.D.
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew M Robinson, Ph.D.
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon State University
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97331
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Insulin and Muscle Fat Metabolism
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