Effect of Testosterone Replacement on Insulin Resistance
Completed · Phase 4 · Has a placebo group
Conditions studied: Metabolic Syndrome, Hypogonadism
In brief
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.
Key facts
- Study ID
- NCT00487734
- Run by
- McGuire Research Institute
- People needed
- 19
- Starts
- 2007-08-01
- Expected to finish
- 2010-10-01
- Last updated by the study team
- 2012-10-23
Who can join
Age: 20 and older, up to 65. Sex: male. Healthy volunteers: not accepted.
You may not qualify if…
- 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:
- Creatinine greater than 1.4 mg/dl
- Triglyceride levels greater than 500 mg/dl
- HDL-C levels less than 20 mg/dl
- Blood pressure greater than 160/90
- The following men will be excluded because of the potential side effects of testosterone therapy:
- Men greater than 65 years of age
- International prostate symptom score >19
- PSA greater than 2.5
- History of benign prostatic hypertrophy
- History of prostate cancer
- Abnormal digital rectal exam
- Hg greater than 16 mg/dl or Hct greater than 48%
- peripheral edema
Where it is running
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.