Healthy Subjects Clinical Trial
— TrainMeUpMNOfficial title:
Training Effects on Fuel Metabolism
Verified date | November 2023 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are interested in how skeletal muscle processes fat and how this may affect insulin resistance. This is an important question since insulin resistance predates and predicts type 2 diabetes. The investigators are especially interested in learning about the effects of weight and training on insulin resistance. The investigators will study people before and after supervised aerobic or yoga training to identify differences in resting fat and sugar metabolism which may lead to differences in insulin resistance. The investigators will test these differences using stable isotopes, and the use of these stable isotopes is experimental. Overweight/Obese Group: Eight visits will be required at the University of Minnesota Clinical Research Unit. Four visits will be done before training (screen and 3 pre-training visits), 1 visit during the training, and 3 post-training visits will be done. In between, the training will take about 16 weeks and will be a supervised treadmill program. Lean/Trained Group: Four visits will be required at the University of Minnesota Clinical Research Unit (screen and 3 study visits).
Status | Active, not recruiting |
Enrollment | 64 |
Est. completion date | December 30, 2025 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: All subjects 1. Subjects 18 to 40 years of age. 2. Subjects are capable of giving informed consent Overweight or obese 1. Insulin resistant based on screening oral glucose tolerance testing. 2. BMI 25 to 40 kg/m2 inclusive 3. Stable weight for at least 3 months (± 5 lbs.) 4. Sedentary status (self-report < 30 minutes/week regular exercise). Lean, physically active 1. physically active subjects defined as 3-5 aerobic exercise sessions/week 2. matched to age and gender 3. generally healthy with normal fasting glucose levels (glucose =100 mg/dL). Exclusion Criteria: All subjects 1. Subjects 18 to 40 years of age. 2. Subjects are capable of giving informed consent Overweight or obese 1. Insulin resistant based on screening oral glucose tolerance testing. 2. BMI 25 to 40 kg/m2 inclusive 3. Stable weight for at least 3 months (± 5 lbs.) 4. Sedentary status (self-report < 30 minutes/week regular exercise). Lean, physically active 1. physically active subjects defined as 3-5 aerobic exercise sessions/week 2. matched to age and gender 3. generally healthy with normal fasting glucose levels (glucose =100 mg/dL). |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Differences in body composition between groups | we will measure body composition by iDEXA to look at changes and total fat, visceral fat, and subcutaneously pre-and post exercise. This will be a noninvasive x-ray based measurement (x-ray exposure is extremely low and is equivalent to 1 day of natural radiation in Minnesota) | before and after exercise program ((exercise program will take 16 weeks, expected average for evaluation will be 20 weeks) | |
Primary | Differences in insulin sensitivity between groups | Will use HOMA-IR and hyperinsulinemia-euglycemic clamp | Before and after exercise program (exercise program will take 16 weeks, expected average for evaluation will be 20 weeks) | |
Secondary | Differences in fitness level between groups | we will measure fitness level by treadmill based VO2 max testing. | before and after exercise program (exercise program will take 16 weeks, expected average for evaluation will be 20 weeks) |
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