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

University at Buffalo

Status

Terminated

Conditions

Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism

Treatments

Drug: androgel

Drug: placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00467987

Androgel 1920

Details and patient eligibility

About

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 .

Full description

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

Enrollment

47 patients

Sex

Male

Ages

31 to 60 years old

Volunteers

Accepts Healthy Volunteers

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%.