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

Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00467987
• Other study ID #: Androgel 1920
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2007
• Est. completion date: October 11, 2018

Study information

• Verified date: February 2024
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: October 11, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 31 Years to 60 Years

Eligibility

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%.

Related Conditions & MeSH terms

• Atherosclerosis
• Hypogonadism
• Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism

Intervention

Drug:
• androgel
androgel 1%
• placebo
placebo

Locations

Country	Name	City	State
United States	Diabetes Endocrinology Research Center of WNY	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carotid Intima Media Thickness	carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm).	2 years
Secondary	Endothelial Function	assessed by brachial artery Flow mediated dilatation (FMD in Centimeters)	2 years