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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00467987
Recruitment Status : Recruiting
First Posted : May 1, 2007
Last Update Posted : November 6, 2017
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Paresh Dandona, 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 .

Condition or disease Intervention/treatment Phase
Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism Drug: androgel Drug: placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : June 2007
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: androgel
Drug: androgel
androgel 1%
Placebo Comparator: placebo
placebo gel
Drug: placebo
Other Name: placebo gel
No Intervention: no treatment
eugonadal comparison arm

Primary Outcome Measures :
  1. carotid intima media thickness [ Time Frame: 2 years ]
    carotid intima media thickness

Secondary Outcome Measures :
  1. endothelial function [ Time Frame: 2 years ]
    assessed by brachial artery Flow mediated dilatation (FMD%)

Information from the National Library of Medicine

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Ages Eligible for Study:   31 Years to 60 Years   (Adult)
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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00467987

Contact: Jeanne Hejna 716-898-1950

United States, New York
Diabetes Endocrinology Research Center of WNY Recruiting
Buffalo, New York, United States, 14215
Contact: Paresh Dandona, MD    716-898-1940      
Sponsors and Collaborators
University at Buffalo
Solvay Pharmaceuticals
Principal Investigator: Paresh Dandona Kaleida Health

Responsible Party: Paresh Dandona, MD, University at Buffalo Identifier: NCT00467987     History of Changes
Other Study ID Numbers: Androgel 1920
First Posted: May 1, 2007    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents