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

Primary Purpose

Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
androgel
placebo
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism

Eligibility Criteria

31 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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%.

Sites / Locations

  • Diabetes Endocrinology Research Center of WNY

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

androgel

placebo

no treatment

Arm Description

androgel

placebo gel

eugonadal comparison arm

Outcomes

Primary Outcome Measures

carotid intima media thickness
carotid intima media thickness

Secondary Outcome Measures

endothelial function
assessed by brachial artery Flow mediated dilatation (FMD%)

Full Information

First Posted
April 27, 2007
Last Updated
November 15, 2022
Sponsor
University at Buffalo
Collaborators
Solvay Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00467987
Brief Title
Effect of Androgel on Atherogenesis in Type 2 Diabetic Males With Hypogonadotrophic Hypogonadism
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Company no longer making drug
Study Start Date
June 2007 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
Solvay Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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 .
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
androgel
Arm Type
Experimental
Arm Description
androgel
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo gel
Arm Title
no treatment
Arm Type
No Intervention
Arm Description
eugonadal comparison arm
Intervention Type
Drug
Intervention Name(s)
androgel
Intervention Description
androgel 1%
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
placebo gel
Intervention Description
placebo
Primary Outcome Measure Information:
Title
carotid intima media thickness
Description
carotid intima media thickness
Time Frame
2 years
Secondary Outcome Measure Information:
Title
endothelial function
Description
assessed by brachial artery Flow mediated dilatation (FMD%)
Time Frame
2 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
31 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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%.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paresh Dandona
Organizational Affiliation
Kaleida Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Endocrinology Research Center of WNY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States

12. IPD Sharing Statement

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

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