Back to resultsExercise and Insulin Signaling in Human Skeletal Muscle
Primary Purpose
Insulin Sensitivity, Obesity, Sedentary Lifestyle
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Insulin Sensitivity focused on measuring exercise
Eligibility Criteria
Inclusion Criteria:
- Males or Females
- Aged 18-45 years
- Normal weight (body mass index [BMI] 18-26 kg/m2) or obese (BMI 30-46 kg/m2)
- Sedentary (< 1 hour of planned physical activity per week for ≥ 6 months)
- Weight stable (< 2 kg change in body mass for ≥ 6 months)
- Non-smokers (no tobacco or nicotine use for ≥ 1 year)
Exclusion Criteria:
- Hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure > 90mmHg)
- Chronic health condition including diabetes, cardiovascular disease, treated hypertension, cancer, anemia, uncontrolled hyper- or hypothyroidism.
- Pregnant, nursing, irregular menses or post-menopausal (if female)
- Hyperglycemia (fasting glucose >126 mg/dl)
- Hypercholesterolemia (fasting LDL>140mg/dl)
- Hemoglobin < 13.0 g/dl (males), < 11.5 g/dl (females)
- Compromised renal function (outside 135-145 mmol/L sodium, 3.5-5.1 mmol/L potassium)
- Lidocaine allergy
- Medications including β-blockers, angiotensin converting enzyme inhibitors, insulin, thiazolidinediones, metformin, sulfonylureas, chronic non-steroidal anti-inflammatory use, anti-coagulant (e.g. warfarin), current antibiotics, opiates, monoamine oxidase inhibitors, benzodiazepines, or others that may impact the study outcomes
- Any physical limitation that prevents a participant from safely completing the exercise test
- Due to the risks associated with the current protocol, individuals with a diminished capacity to consent will be excluded. Similarly, due to the need for constant, accurate participant monitoring during metabolic study activities, participants will need to clearly understand verbal and written English. Participants who cannot clearly understand verbal and written English will be excluded.
Sites / Locations
- Oregon State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise Metabolic Study Day
Resting Metabolic Study Day
Arm Description
Participants will perform a single bout of moderate intensity exercise on a cycle ergometer for 60 minutes. A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers.
Participants will rest quietly in bed for 60 minutes and resting energy metabolism will be measured with a ventilated hood. A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers.
Outcomes
Primary Outcome Measures
Skeletal muscle insulin sensitivity
Skeletal muscle insulin sensitivity will be measured by hyperinsulinemic-euglycemic clamp.
Secondary Outcome Measures
Full Information
NCT ID
NCT02987491
First Posted
November 21, 2016
Last Updated
August 23, 2019
Sponsor
Oregon State University
1. Study Identification
Unique Protocol Identification Number
NCT02987491
Brief Title
Exercise and Insulin Signaling in Human Skeletal Muscle
Official Title
Exercise and Insulin Signaling in Human Skeletal Muscle
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 28, 2018 (Actual)
Study Completion Date
June 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obesity is associated with a decrease in skeletal muscle insulin sensitivity. Aerobic exercise can increase insulin sensitivity in the few hours following exercise, however the cellular mechanisms are not completely understood. The current project is to investigate mechanisms of exercise improvements to skeletal muscle insulin sensitivity.
Detailed Description
Study Overview: We are investigating the mechanisms by which exercise improves the response of skeletal muscle to insulin in lean and obese adults. Participants will complete 4 study visits consisting of: 1) screening visit, 2) maximal exercise test visit, and then a randomized order of 3) a resting metabolic study visit, and 4) an exercise metabolic study visit. Metabolic study visits for resting and exercise conditions will be identical, other than remaining sedentary or performing exercise. Skeletal muscle biopsy samples will be collected during resting, immediately post-exercise and during insulin stimulated conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Obesity, Sedentary Lifestyle
Keywords
exercise
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Metabolic Study Day
Arm Type
Experimental
Arm Description
Participants will perform a single bout of moderate intensity exercise on a cycle ergometer for 60 minutes.
A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers.
Arm Title
Resting Metabolic Study Day
Arm Type
No Intervention
Arm Description
Participants will rest quietly in bed for 60 minutes and resting energy metabolism will be measured with a ventilated hood.
A total of 3 muscle biopsies will be collected throughout the study day. Insulin sensitivity will be measured using a hyperinsulinemic-euglycemic clamp with glucose tracers.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Participants will perform 2 metabolic study days of either resting or acute bout of cycling exercise in a randomized cross-over design.
Primary Outcome Measure Information:
Title
Skeletal muscle insulin sensitivity
Description
Skeletal muscle insulin sensitivity will be measured by hyperinsulinemic-euglycemic clamp.
Time Frame
2 hours following rest or exercise
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males or Females
Aged 18-45 years
Normal weight (body mass index [BMI] 18-26 kg/m2) or obese (BMI 30-46 kg/m2)
Sedentary (< 1 hour of planned physical activity per week for ≥ 6 months)
Weight stable (< 2 kg change in body mass for ≥ 6 months)
Non-smokers (no tobacco or nicotine use for ≥ 1 year)
Exclusion Criteria:
Hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure > 90mmHg)
Chronic health condition including diabetes, cardiovascular disease, treated hypertension, cancer, anemia, uncontrolled hyper- or hypothyroidism.
Pregnant, nursing, irregular menses or post-menopausal (if female)
Hyperglycemia (fasting glucose >126 mg/dl)
Hypercholesterolemia (fasting LDL>140mg/dl)
Hemoglobin < 13.0 g/dl (males), < 11.5 g/dl (females)
Compromised renal function (outside 135-145 mmol/L sodium, 3.5-5.1 mmol/L potassium)
Lidocaine allergy
Medications including β-blockers, angiotensin converting enzyme inhibitors, insulin, thiazolidinediones, metformin, sulfonylureas, chronic non-steroidal anti-inflammatory use, anti-coagulant (e.g. warfarin), current antibiotics, opiates, monoamine oxidase inhibitors, benzodiazepines, or others that may impact the study outcomes
Any physical limitation that prevents a participant from safely completing the exercise test
Due to the risks associated with the current protocol, individuals with a diminished capacity to consent will be excluded. Similarly, due to the need for constant, accurate participant monitoring during metabolic study activities, participants will need to clearly understand verbal and written English. Participants who cannot clearly understand verbal and written English will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Robinson, PhD
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
Citations:
PubMed Identifier
34127633
Citation
Newsom SA, Stierwalt HD, Ehrlicher SE, Robinson MM. Substrate-Specific Respiration of Isolated Skeletal Muscle Mitochondria after 1 h of Moderate Cycling in Sedentary Adults. Med Sci Sports Exerc. 2021 Jul 1;53(7):1375-1384. doi: 10.1249/MSS.0000000000002615.
Results Reference
derived
PubMed Identifier
32796254
Citation
Stierwalt HD, Ehrlicher SE, Robinson MM, Newsom SA. Skeletal Muscle ACSL Isoforms Relate to Measures of Fat Metabolism in Humans. Med Sci Sports Exerc. 2021 Mar 1;53(3):624-632. doi: 10.1249/MSS.0000000000002487.
Results Reference
derived
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Exercise and Insulin Signaling in Human Skeletal Muscle
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