Effect of Testosterone Gel Replacement on Fat Mass in Males With Low Testosterone Levels and Diabetes

Exclusion Criteria

• •Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks
• •Hepatic disease (transaminase \> 3 times normal)
• •Renal impairment (serum creatinine \> 1.5)
• •Chronic steroid therapy
• •Use of testosterone or other androgens (such as DHEA) in the last 3 months
• •Panhypopituitarism
• •HIV or hepatitis C
• •Subjects will be excluded from the study for history of prostate or breast cancer, gonadal endocrine disorders
• •Current or recent history of major psychiatric illness, significant uncontrolled systemic illness
• •Sleep apnea
• •History of alcoholism or substance abuse within the past year
• •History of taking other drugs that might interfere with the results of the study (ie, Lupron, finasteride, spironolactone, cimetidine, antiandrogens, estrogens, p450 enzyme inducers, barbiturates)
• •Abnormal prostate evidenced by prostatic symptoms, prostatic masses or induration on rectal examination, elevated levels of prostate specific antigen (\>4 ng/mL; subjects with PSA levels between 2.5-4 ng/mL will be permitted if prostate biopsy is negative) or positive biopsy, a urine flow rate of less than 12 mL/s, or an International Prostate Symptom Score greater than 19
• •Hematocrit greater than 50%
• •Body weight \>300 lbs (this is the maximum weight that can be accommodated on DEXA or MRI machines.
• •The subject has systolic blood pressure \>170mmHg or diastolic blood pressure \>100 mmHg while on or off anti-hypertensive treatment.
• •Generalized skin disease that could affect the absorption of testosterone gel (ie, psoriasis);
• •Morning prolactin level greater than 40 mg/mL
• •Subjects with serum fasting triglyceride concentration \> 500 mg/dL at screening or with history of hypertriglyceridemia-induced pancreatitis.
• •Participation in any other concurrent clinical trial
• •Any other life-threatening, non-cardiac disease
• •Use of an investigational agent or therapeutic regimen within 30 days or 5 half-lives (which ever is longer) preceding the first dose of study medication.