Effect of Testosterone Replacement on Insulin Resistance

Phase 4

Completed

• Conditions: Hypogonadism; Metabolic Syndrome
• Interventions: Drug: Placebo for testosterone gel; Radiation: Testosterone gel

• Registration Number: NCT00487734
• Lead Sponsor: McGuire Research Institute

Brief 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.

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.

Study Timeline

• Study First Submitted: 2007-06-15
• Study First Submitted QC: 2007-06-18
• Study First Posted: 2007-06-19
• Study Start: 2007-08
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-22
• Last Update Posted: 2012-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo for testosterone gel	-
1	Testosterone gel	Subjects in this arm will receive testosterone gel

Primary Outcome Measures

Name	Time	Method
Change in insulin sensitivity as measured by HOMA-IR	18 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in body composition	18 weeks
Changes in total and high MW adiponectin levels	18 weeks
Changes in parameters of the Metabolic Syndrome	18 weeks

Trial Locations

Locations (1)

Hunter Holmes McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States