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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


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 Syndrome

Changes 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.


Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Male.


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

Page last updated: August 23, 2015

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