Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Effect of Testosterone Replacement on Insulin Resistance

This study has been completed.
Solvay Pharmaceuticals
Information provided by (Responsible Party):
McGuire Research Institute Identifier:
First received: June 15, 2007
Last updated: October 22, 2012
Last verified: October 2012
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
Radiation: Testosterone gel
Drug: Placebo for testosterone gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]

Secondary Outcome Measures:
  • 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 ]

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.

Ages Eligible for Study:   20 Years to 65 Years   (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
  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 identifier: NCT00487734

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

Responsible Party: McGuire Research Institute Identifier: NCT00487734     History of Changes
Other Study ID Numbers: 01274
Study First Received: June 15, 2007
Last Updated: October 22, 2012

Keywords provided by McGuire Research Institute:
Metabolic Syndrome
Insulin Resistance

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on April 28, 2017