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

NCT ID: NCT00467987

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-01
• Study Completion Date: 2018-10-11

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

Conditions

Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

androgel

androgel

Group Type: EXPERIMENTAL

androgel

Intervention Type: DRUG

androgel 1%

placebo

placebo gel

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

no treatment

eugonadal comparison arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

androgel

androgel 1%

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

placebo gel

Eligibility 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%.

• Minimum Eligible Age: 31 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Solvay Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

University at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Paresh Dandona

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paresh Dandona

Role: PRINCIPAL_INVESTIGATOR

Kaleida Health

Locations

Diabetes Endocrinology Research Center of WNY

Buffalo, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Androgel 1920

Identifier Type: -

Identifier Source: org_study_id