Effect of Testosterone Replacement on Insulin Resistance

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGuire Research Institute
• Collaborator: Solvay Pharmaceuticals
• Treatments: Insulin; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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