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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Kaleida Health
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health
ClinicalTrials.gov Identifier:
NCT00467987
First received: April 27, 2007
Last updated: December 17, 2012
Last verified: December 2012
  Purpose

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 Intervention
Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism
Drug: androgel
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Kaleida Health:

Primary Outcome Measures:
  • carotid intima media thickness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    carotid intima media thickness


Secondary Outcome Measures:
  • endothelial function [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    assessed by brachial artery Flow mediated dilatation (FMD%)


Estimated Enrollment: 80
Study Start Date: June 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: androgel
androgel
Drug: androgel
androgel 1%
Placebo Comparator: placebo
placebo gel
Drug: placebo
placebo
Other Name: placebo gel
No Intervention: no treatment
eugonadal comparison arm

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

  Eligibility

Ages Eligible for Study:   31 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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%.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467987

Contacts
Contact: Jeanne Hejna 716-626-7998 jhejna@kaleidahealth.org

Locations
United States, New York
115 Flint Road Recruiting
Williamsville, New York, United States, 14221
Contact: Jeane Hejna         
Sponsors and Collaborators
Kaleida Health
Solvay Pharmaceuticals
Investigators
Principal Investigator: Paresh Dandona Kaleida Health
  More Information

No publications provided

Responsible Party: Paresh Dandona, MD, MD, Kaleida Health
ClinicalTrials.gov Identifier: NCT00467987     History of Changes
Other Study ID Numbers: Androgel 1920
Study First Received: April 27, 2007
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypogonadism
Endocrine System Diseases
Gonadal Disorders
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014