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Effect of Testosterone Replacement on Insulin Resistance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487734
Recruitment Status : Completed
First Posted : June 19, 2007
Last Update Posted : October 23, 2012
Solvay Pharmaceuticals
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Hypogonadism Radiation: Testosterone gel Drug: Placebo for testosterone gel Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome
Study Start Date : August 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in insulin sensitivity as measured by HOMA-IR [ Time Frame: 18 weeks ]

Secondary Outcome Measures :
  1. Changes in parameters of the Metabolic Syndrome [ Time Frame: 18 weeks ]
  2. Changes in body composition [ Time Frame: 18 weeks ]
  3. Changes in total and high MW adiponectin levels [ Time Frame: 18 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes 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):

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00487734

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United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
McGuire Research Institute
Solvay Pharmaceuticals
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Principal Investigator: Sonja K Fredrickson, MD Hunter Holmes McGuire VA Medical Center

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Responsible Party: McGuire Research Institute Identifier: NCT00487734     History of Changes
Other Study ID Numbers: 01274
First Posted: June 19, 2007    Key Record Dates
Last Update Posted: October 23, 2012
Last Verified: October 2012
Keywords provided by McGuire Research Institute:
Metabolic Syndrome
Insulin Resistance
Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents