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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
  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

Resource links provided by NLM:


Further study details as provided by McGuire Research Institute:

Primary Outcome Measures:
  • Change in insulin sensitivity as measured by HOMA-IR [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487734

Locations
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
McGuire Research Institute
Solvay Pharmaceuticals
Investigators
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
Syndrome
Disease
Endocrine System Diseases
Glucose Metabolism Disorders
Gonadal Disorders
Hyperinsulinism
Metabolic Diseases
Pathologic Processes
Insulin
Methyltestosterone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Androgens
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014