Effect of Androgel on Type 2 Diabetic Males With Hypogonadism

Type 2 diabetes is an atherosclerotic, pro-inflammatory and pro-oxidative stress.
Hypogonadism( low testosterone) is also associated with increased levels of inflammatory
mediators and atherosclerosis.

This project is about studying the effect of testosterone replacement on different
inflammatory cells in blood and urine. It will also compare the dose dependent effect on
inflammatory cells. This also involves comparing level of inflammation in hypogonadic
diabetic males treated with testosterone with those not treated with any replacement
therapy.

This study involves applying AndroGel for 8 wks and studying effects during this time and
thereafter.

Inclusion Criteria:

- Males with age 35-75 years inclusive.

- Evidence of hypogonadism: low free testosterone.

- Type 2 Diabetes

- People on stable doses of cholesterol lowering medications, blood pressure
medications and multi-vitamins are allowed.

- If currently on testosterone replacement,testosterone treatment will be held for 8
weeks.

- BP under control even if on medication.

Exclusion Criteria:

- Coronary event or procedure in previous past 4 wks.

- High PSA

- H/O prostate cancer

- Hepatic or renal disease

- Participation in any other concurrent clinical trial

- Any other life- threatening , non cardiac disease.

- Uncontrolled BP

- Congestive heart failure

- High hemoglobin

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