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

NCT00467987 | Terminated Results

• 1 other identifier: Androgel 1920
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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 .

Conditions

Type 2 Diabetic Male With Hypogonadotrophic Hypogonadism

Outcome Measures

Primary Outcomes (1)

• Carotid Intima Media Thickness

  carotid intima media thickness measured at baseline 0 months and at 2 years in centimeters (cm).

  2 years

Secondary Outcomes (1)

• Endothelial Function

  2 years

Study Arms (3)

androgel

EXPERIMENTAL

androgel

Drug: androgel

placebo

PLACEBO COMPARATOR

placebo gel

Drug: placebo

no treatment

NO INTERVENTION

eugonadal comparison arm

Interventions

androgel DRUG

androgel 1%

androgel

placebo DRUG

placebo

Also known as: placebo gel

placebo

Eligibility Criteria

• Age: 31 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• University at Buffalo: lead
• Solvay Pharmaceuticals: collaborator

Study Sites (1)

Diabetes Endocrinology Research Center of WNY

Buffalo, New York, 14215, United States

Location

MeSH Terms

Interventions

Testosterone

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Paresh Dandona
• Organization: State University of NY at Buffalo

dandona@buffalo.edu

17165351852

Study Officials

• Paresh Dandona

  Kaleida Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: matching placebo
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: May 1, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2018
• Study Completion: October 11, 2018
• Last Updated: February 6, 2024
• Results First Posted: February 6, 2024

Record last verified: 2024-02

Locations

US (1)