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

Information source: University at Buffalo
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism

Intervention: androgel (Drug); placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University at Buffalo

Official(s) and/or principal investigator(s):
Paresh Dandona, Principal Investigator, Affiliation: Kaleida Health

Overall contact:
Jeanne Hejna, Phone: 716-626-7998, Email: jhejna@kaleidahealth.org

Summary

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 .

Clinical Details

Official title: Effect of Androgel on Atherogenesis, Inflammation, Cardiovascular Risk Factors And Adiposity in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism.: a Prospective, Randomized and Controlled-Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: carotid intima media thickness

Secondary outcome: endothelial function

Detailed 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

Eligibility

Minimum age: 31 Years. Maximum age: 60 Years. Gender(s): Male.

Criteria:

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%.

Locations and Contacts

Jeanne Hejna, Phone: 716-626-7998, Email: jhejna@kaleidahealth.org

115 Flint Road, Williamsville, New York 14221, United States; Recruiting
Jeane Hejna
Additional Information

Starting date: June 2007
Last updated: April 29, 2015

Page last updated: August 20, 2015

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