Effect of Testosterone Replacement on Insulin Resistance
Information source: McGuire Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome; Hypogonadism
Intervention: Testosterone gel (Radiation); Placebo for testosterone gel (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: McGuire Research Institute Official(s) and/or principal investigator(s): Sonja K Fredrickson, MD, Principal Investigator, Affiliation: Hunter Holmes McGuire VA Medical Center
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.
Clinical Details
Official title: Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in insulin sensitivity as measured by HOMA-IR
Secondary outcome: Changes in parameters of the Metabolic SyndromeChanges in body composition Changes in total and high MW adiponectin levels
Detailed 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.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Male.
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
Locations and Contacts
Hunter Holmes McGuire VA Medical Center, Richmond, Virginia 23249, United States
Additional Information
Starting date: August 2007
Last updated: October 22, 2012
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