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

Not Applicable

Terminated

• Conditions: Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism
• Interventions: Drug: placebo; Drug: androgel

• Registration Number: NCT00467987
• Lead Sponsor: University at Buffalo

Brief 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 .

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

Study Timeline

• Study First Submitted: 2007-04-27
• Study First Submitted QC: 2007-04-27
• Study First Posted: 2007-05-01
• Study Start: 2007-06-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-10-11
• Results First Submitted: 2024-01-03
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-03
• Last Update Submitted: 2024-02-03
• Results First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 47

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo gel
androgel	androgel	androgel

Primary Outcome Measures

Name	Time	Method
Carotid Intima Media Thickness	2 years	carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm).

Secondary Outcome Measures

Name	Time	Method
Endothelial Function	2 years	assessed by brachial artery Flow mediated dilatation (FMD in Centimeters)

Trial Locations

Locations (1)

Diabetes Endocrinology Research Center of WNY; 🇺🇸 Buffalo, New York, United States