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

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

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 .

Study Overview

• Status: Terminated
• Conditions: Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism
• Intervention / Treatment: Drug: placebo; Drug: androgel

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
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14215
      • Diabetes Endocrinology Research Center of WNY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 31 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: androgel	Drug: androgel; androgel 1%
Placebo Comparator: placebo; placebo gel	Drug: placebo; placebo; Other Names: placebo gel
No Intervention: no treatment; eugonadal comparison arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carotid Intima Media Thickness	carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Function	assessed by brachial artery Flow mediated dilatation (FMD in Centimeters)	2 years

Collaborators and Investigators

• Sponsor: University at Buffalo
• Collaborators: Solvay Pharmaceuticals
• Investigators: Principal Investigator: Paresh Dandona, Kaleida Health

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2007
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): October 11, 2018

Study Registration Dates

• First Submitted: April 27, 2007
• First Submitted That Met QC Criteria: April 27, 2007
• First Posted (Estimated): May 1, 2007

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Atherosclerosis; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: Androgel 1920