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Effect of Androgel on Atherogenesis, Inflammation, Cardiovascular Risk Factors And Adiposity in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism
This study is not yet open for participant recruitment.
Verified by Kaleida Health, April 2007
Sponsored by: Kaleida Health
Information provided by: Kaleida Health
ClinicalTrials.gov Identifier: NCT00467987
  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

MedlinePlus related topics: Obesity
Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Kaleida Health:

Study Start Date: June 2007
Estimated Study Completion Date: June 2012
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467987

Contacts
Contact: Barbara Hall 716-887-5104 bhall@kaleidahealth.org

Locations
United States, New York
Millard Fillmore Hospital
Buffalo, New York, United States, 14209
Sponsors and Collaborators
Kaleida Health
Investigators
Principal Investigator: Paresh Dandona Kaleida Health
  More Information

Study ID Numbers: Androgel 1920
Study First Received: April 27, 2007
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00467987  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Atherosclerosis
Arterial Occlusive Diseases
Obesity
Gonadal Disorders
Vascular Diseases
Endocrine System Diseases
Arteriosclerosis
Methyltestosterone
Inflammation
Testosterone 17 beta-cypionate
Testosterone
Hypogonadism
Endocrinopathy

Additional relevant MeSH terms:
Anabolic Agents
Pathologic Processes
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Diseases
Hormones
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 15, 2009