Status:
UNKNOWN
Metabolic Effects of Steroids in Obese Men
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
University of California, San Diego
Conditions:
Obesity
Insulin Resistance
Eligibility:
MALE
24-51 years
Phase:
NA
Brief Summary
Subjects will be randomized into 4 study groups: 1. Placebo; 2. Anastrazole and Testosterone; 3. Dutasteride and Testosterone; and 4. Testosterone only. A 2 step euglycemic clamp, body composition by ...
Eligibility Criteria
Inclusion
- free T level in the lower 25% of the normal range or below
- BMI ≥30kg/m2
- waist circumference ≥100cm
Exclusion
- pituitary tumors
- HIV infection
- Klinefelter's syndrome
- Kallman's syndrome
- uncontrolled hypertension
- diabetes
- congestive heart failure
- chronic lung disease
- acute coronary syndrome
- PSA \>4µg/L
- aspartate aminotransferase (AST)\> 3x upper limit of normal
- use of medications that might affect weight loss, muscle or bone metabolism or androgen metabolism, action or clearance.
- involvement in daily resistance training or high endurance exercise
- alcohol or drug dependence
- obstructive sleep apnea
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00983554
Start Date
June 1 2005
End Date
October 1 2009
Last Update
March 16 2011
Active Locations (2)
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1
University of California, San Diego
San Diego, California, United States, 92103
2
VA San Diego Healthcare System
San Diego, California, United States, 92161