Effect of Androgel on Atherogenesis in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism

The purpose of this study is to examine the effects of testosterone deficiency in men with
diabetes on atherogenesis, inflammation, cardiovascular Risk factors And adiposity . This
will be done by comparing the changes in several body response indicators following treatment
with testosterone in diabetic men with low testosterone levels and comparing them to diabetic
men with low testosterone who are not treated with testosterone. These groups will also be
compared with diabetic men who have normal testosterone levels

Inclusion Criteria:

- Males with age 30-60 years inclusive.

- PSA < 2.6 ng/ml or < 3.75 ng/ml with a negative prostate biopsy in the last 6 months.

- IPSS ≤ 19. The lower age limit was decided on the fact that in our study on
hypogonadotrophic hypogonadism in type 2 diabetic patients, the youngest subject was
31 years old. The upper age limit has been restricted to 60 to avoid including
subjects with significant age-related declines in testosterone concentrations.Subjects
on thiazolidinediones, statins, ACE inhibitors, angiotensin receptor blockers or
antioxidants will be allowed as long as they are on stable doses of these compounds
and the dosage in not changed during the study. Subjects on insulin, metformin or
sulfonylureas can participate in the study, provided that minimal changes are made to
the doses during the study

Exclusion Criteria:

- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery
bypass, surgery or coronary angioplasty) in the previous four weeks; 2)Hemoglobin A1c
>10%;

- h/o prostate carcinoma;

- Hepatic disease (transaminase > 3 times normal) or cirrhosis;

- Renal impairment (serum creatinine > 1.5);

- HIV or Hepatitis C positive status;

- Participation in any other concurrent clinical trial;

- Any other life-threatening, non-cardiac disease;

- Use of over the counter health supplements which contain androgens;

- Use of an investigational agent or therapeutic regimen within 30 days of study.

- Use of testosterone in the past

- Hematocrit > 50%.