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

Sponsor
University at Buffalo (Other)
Overall Status
Unknown status
CT.gov ID
NCT00467987
Collaborator
Solvay Pharmaceuticals (Industry)
80
Enrollment
1
Location
3
Arms
150
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 1, 2007
Anticipated Primary Completion Date :
Jun 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: androgel

androgel

Drug: androgel
androgel 1%
Placebo Comparator: placebo

placebo gel

Drug: placebo
placebo
Other Names:
  • placebo gel

    		•
    No Intervention: no treatment

    eugonadal comparison arm

    Outcome Measures

    Primary Outcome Measures

    1. carotid intima media thickness [2 years]

      carotid intima media thickness

    Secondary Outcome Measures

    1. endothelial function [2 years]

      assessed by brachial artery Flow mediated dilatation (FMD%)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    31 Years to 60 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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%.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Diabetes Endocrinology Research Center of WNY Buffalo New York United States 14215

    Sponsors and Collaborators

    • University at Buffalo
    • Solvay Pharmaceuticals

    Investigators

    • Principal Investigator: Paresh Dandona, Kaleida Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paresh Dandona, MD, University at Buffalo
    ClinicalTrials.gov Identifier:
    NCT00467987
    Other Study ID Numbers:
    • Androgel 1920
    First Posted:
    May 1, 2007
    Last Update Posted:
    Nov 6, 2017
    Last Verified:
    Nov 1, 2017
    Additional relevant MeSH terms:
    Atherosclerosis
    Hypogonadism
    Testosterone

    Study Results

    No Results Posted as of Nov 6, 2017