Effect of Testosterone Replacement on Insulin Resistance

Metabolic Syndrome Clinical Trial

Official title:

Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487734
• Other study ID #: 01274
• Status: Completed
• Phase: Phase 4
• First received: June 15, 2007
• Last updated: October 22, 2012
• Start date: August 2007
• Est. completion date: October 2010

Study information

• Verified date: October 2012
• Source: McGuire Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study aims to determine whether testosterone replacement improves insulin sensitivity in non-obese men with low testosterone and the metabolic syndrome. The metabolic syndrome includes three of the following five conditions, 1) an elevated blood pressure (greater than 130/85), 2) a triglyceride level greater than 150 mg/dl, 3) an HDL-cholesterol less than 40 mg/dl, 4) glucose levels greater than 100 mg/dl, and 5) a waist measurement greater than 40 inches.

Description:

In this proposal, we will examine the relationship between hypogonadism and insulin sensitivity. The strongest relationship between hypogonadism and insulin resistance appears to reside in men with the metabolic syndrome who have a normal BMI. The causal relationship between these two conditions is unknown. Therefore, we propose to determine if testosterone replacement in hypogonadal non-obese men with metabolic syndrome will improve insulin sensitivity. Data obtained from this preliminary investigation, will hopefully result in a hypothesis that can be tested in a larger, more rigorous trial in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria: (subjects must meet both criteria)

• Metabolic syndrome (have 3 out of the following 4 criteria):

1. BP > 130/85 or on antihypertensive therapy

2. Fasting glucose > 100 mg/dl

3. Fasting TG > 150 mg/dl or on a triglyceride lowering agent (fenofibrate, gemfibrozil, niacin in doses of >= 500 mg/day, or fish oils in doses of >=2000mg DHA+EPA)

4. Fasting HDL-C < 40 mg/dl Note that the waist circumference will not be used as one of the criteria for the metabolic syndrome for this study because we are studying non-obese subjects.

• Total Testosterone less than 300 ng/dl

Exclusion Criteria:

• Women.

• Men less than 20 years of age.

• BMI > or = to 30 kg/M2.

• Use of testosterone preparations within 1 year of the screening visit

• Use of hypoglycemic medications within the previous 3 months.

• Fasting blood glucose > 126 mg/dl.

• The following men will be excluded because of the potential safety issues in the placebo treated group:

1. Creatinine greater than 1.4 mg/dl

2. Triglyceride levels greater than 500 mg/dl

3. HDL-C levels less than 20 mg/dl

4. Blood pressure greater than 160/90

• The following men will be excluded because of the potential side effects of testosterone therapy:

1. Men greater than 65 years of age

2. International prostate symptom score >19

3. PSA greater than 2.5

4. History of benign prostatic hypertrophy

5. History of prostate cancer

6. Abnormal digital rectal exam

7. Hg greater than 16 mg/dl or Hct greater than 48%

8. peripheral edema

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Radiation:
• Testosterone gel
testosterone gel, applied daily. Dosed to achieve testosterone level <500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.

Drug:
• Placebo for testosterone gel
Placebo gel, 2.5g for each gel packet

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
McGuire Research Institute	Solvay Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity as measured by HOMA-IR		18 weeks	No
Secondary	Changes in parameters of the Metabolic Syndrome		18 weeks	No
Secondary	Changes in body composition		18 weeks	No
Secondary	Changes in total and high MW adiponectin levels		18 weeks	No