Metabolic Effects of Steroids in Obese Men
Status unconfirmed · Not applicable
Conditions studied: Obesity, Insulin Resistance
In brief
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 dual X-ray absorptiometry scan, hormone and lipid assays will be performed to monitor metabolic effects of each treatment group. We hypothesize that increasing testosterone levels would increase lean mass, decrease fat mass and improve insulin sensitivity. We further hypothesize that improvements in the metabolic profile would decrease with anastrazole and improve with dutasteride, given in conjunction with T administration.
Key facts
- Study ID
- NCT00983554
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 57
- Starts
- 2005-06-01
- Expected to finish
- 2009-10-01
- Last updated by the study team
- 2011-03-16
Who can join
Age: 24 and older, up to 51. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- free T level in the lower 25% of the normal range or below
- BMI ≥30kg/m2
- waist circumference ≥100cm
You may not qualify if…
- 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
Where it is running
- University of California, San Diego — San Diego, California, United States
- VA San Diego Healthcare System — San Diego, California, United States
Full record on ClinicalTrials.gov
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