Effect of Testosterone Replacement on Insulin Resistance
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Metabolic Syndrome Hypogonadism |
Radiation: Testosterone gel Drug: Placebo for testosterone gel |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome |
- Change in insulin sensitivity as measured by HOMA-IR [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Changes in parameters of the Metabolic Syndrome [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Changes in body composition [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
- Changes in total and high MW adiponectin levels [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 19 |
| Study Start Date: | August 2007 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Subjects in this arm will receive testosterone gel
|
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.
Other Name: Androgel
|
| Placebo Comparator: 2 |
Drug: Placebo for testosterone gel
Placebo gel, 2.5g for each gel packet
|
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| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: (subjects must meet both criteria)
Metabolic syndrome (have 3 out of the following 4 criteria):
- BP > 130/85 or on antihypertensive therapy
- Fasting glucose > 100 mg/dl
- 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)
- 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:
- 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
Contacts and Locations| United States, Virginia | |
| Hunter Holmes McGuire VA Medical Center | |
| Richmond, Virginia, United States, 23249 | |
| Principal Investigator: | Sonja K Fredrickson, MD | Hunter Holmes McGuire VA Medical Center |
More Information
No publications provided
| Responsible Party: | McGuire Research Institute |
| ClinicalTrials.gov Identifier: | NCT00487734 History of Changes |
| Other Study ID Numbers: | 01274 |
| Study First Received: | June 15, 2007 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by McGuire Research Institute:
|
Metabolic Syndrome Hypogonadism Insulin Resistance |
Additional relevant MeSH terms:
|
Hypogonadism Insulin Resistance Metabolic Syndrome X Gonadal Disorders Endocrine System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate |
Methyltestosterone Insulin Androgens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents Hypoglycemic Agents |
ClinicalTrials.gov processed this record on June 18, 2013