Effect of Testosterone Replacement on Insulin Resistance

This study has been completed.
Sponsor:
Collaborator:
Solvay Pharmaceuticals
Information provided by (Responsible Party):
McGuire Research Institute
ClinicalTrials.gov Identifier:
NCT00487734
First received: June 15, 2007
Last updated: October 22, 2012
Last verified: October 2012

June 15, 2007
October 22, 2012
August 2007
October 2010   (final data collection date for primary outcome measure)
Change in insulin sensitivity as measured by HOMA-IR [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Change in insulin sensitivity as measured by HOMA-IR [ Time Frame: 18 weeks ]
Complete list of historical versions of study NCT00487734 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Changes in parameters of the Metabolic Syndrome [ Time Frame: 18 weeks ]
  • Changes in body composition [ Time Frame: 18 weeks ]
  • Changes in total and high MW adiponectin levels [ Time Frame: 18 weeks ]
Not Provided
Not Provided
 
Effect of Testosterone Replacement on Insulin Resistance
Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Metabolic Syndrome
  • Hypogonadism
  • 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
  • Drug: Placebo for testosterone gel
    Placebo gel, 2.5g for each gel packet
  • Experimental: 1
    Subjects in this arm will receive testosterone gel
    Intervention: Radiation: Testosterone gel
  • Placebo Comparator: 2
    Intervention: Drug: Placebo for testosterone gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Male
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00487734
01274
No
McGuire Research Institute
McGuire Research Institute
Solvay Pharmaceuticals
Principal Investigator: Sonja K Fredrickson, MD Hunter Holmes McGuire VA Medical Center
McGuire Research Institute
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP