Status:
COMPLETED
ACTIV- Exercise Intervention in Healthy Young Men
Lead Sponsor:
Pennington Biomedical Research Center
Conditions:
Insulin Resistance
Eligibility:
MALE
25-35 years
Phase:
NA
Brief Summary
The study is designed to compare muscle energy capacity in men with obesity or diabetes as compared to athletes. This study will also enable researchers to determine whether MRS can replace muscle bio...
Detailed Description
Skeletal muscle mitochondrial defects are a sine qua non of insulin resistance in patients with type 2 diabetes mellitus (T2DM), obese and subjects with family history of T2DM (FH+). Exercise increase...
Eligibility Criteria
Inclusion
- T2DM group:
- Men aged 25-35
- BMI \> 30 kg/m2
- Sedentary lifestyle determined by activity index questionnaire (not involved in regular exercise program) and accelerometer data.
- Are willing to eat only foods provided by Pennington for the study period
- Diagnosed with T2DM defined by one or more of the following:
- fasting plasma glucose \> 126 mg/dL at entry
- a two-hour OGTT glucose \> 200mg/dL
- current medication for T2DM
- Obese group:
- Men aged 25-35
- BMI \> 30 kg/m2
- Sedentary lifestyle activity index questionnaire (not involved in regular exercise program) and accelerometer data.
- Are willing to eat only foods provided by Pennington for the study period
- FH+ group:
- Men aged 25-35
- One parent diagnosed with T2DM
- fasting insulin \> 10mIU/ml (\> 50th %tile)
- BMI between 22 and 30 kg/m2
- Sedentary lifestyle activity index questionnaire (not involved in regular exercise program) and accelerometer data.
- Are willing to exercise every day for the study period
- Are willing to eat only foods provided by Pennington for the study period
- FH- group:
- Men aged 25-35
- Parents and grandparents were not diagnosed with T2DM
- Fasting insulin \< 10mIU/ml (\< 50th %tile)
- BMI between 22 and 30 kg/m2
- Sedentary lifestyle activity index questionnaire (not involved in regular exercise program) and accelerometer data.
- Are willing to exercise for the study period
- Are willing to eat only foods provided by Pennington for the study period
- Athlete group:
- Men aged 25-35
- Maximal oxygen uptake \> 60 ml/kg.min
- Are engaged in minimum of 1.5 h of aerobic exercise 3 times/ week
- Are willing to eat only foods provided by Pennington for the study period
Exclusion
- Abnormal resting or exercise ECG
- Significant renal, cardiac, liver, lung, or neurological disease (controlled hypertension is acceptable if baseline bp \< 140/90 on medications)
- Use of drugs known to affect energy metabolism or body weight: including, but not limited to: orlistat, sibutramine, ephedrine, phenylpropanolamine, corticosterone, etc
- Alcohol or other drug abuse
- Smoking
- Gait problems
- Unwilling or unable to abstain from caffeine (48h) prior to metabolic rate measurements
- Unwilling or unable to eat all study foods
- Increased liver function tests at baseline (AST/ALT/GGT/or alkaline phosphatase greater than 2.5 times the upper limit of normal)
- Metal objects that would interfere with the measurement of body composition /MRS such as implanted rods, surgical clips, etc
- NYHA class III/IV CHF is an exclusionary cardiac condition
- history of deep vein thrombosis (DVT) or pulmonary embolism (PE)
- varicose veins
- major surgery on the abdomen, pelvis, or lower extremities within previous 3 months
- cancer (active malignancy with or without concurrent chemotherapy)
- rheumatoid disease
- bypass graft in limb
- known genetic factor (Factor V Leiden, etc) or hypercoagulable state
- diagnosed peripheral arterial or vascular disease, or intermittent claudication
- family history of primary DVT or PE (pulmonary embolism)
- peripheral neuropathy
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00401791
Start Date
November 1 2006
End Date
October 1 2016
Last Update
September 21 2022
Active Locations (1)
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1
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808