Effect of Testosterone Replacement on Insulin Resistance - Full Text View

Sponsor:	McGuire Research Institute
Collaborator:	Solvay Pharmaceuticals
Information provided by:	McGuire Research Institute
ClinicalTrials.gov Identifier:	NCT00487734

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-Obese Men With Metabolic Syndrome

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Insulin Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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 ]

Estimated Enrollment:	24
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Placebo Comparator	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

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

Contacts

Contact: Helen Stewart, RN	(804)675-5000 ext 4903	helen.stuart@va.gov
Contact: Sonja K Fredrickson, MD	(804)675-5535	sonja.fredrickson@va.gov

Locations

United States, Virginia
Hunter Holmes McGuire VA Medical Center	Recruiting
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:	Richmond VA Medical Center/McGuire Research Institute ( Sonja Fredrickson MD )
Study ID Numbers:	01274
Study First Received:	June 15, 2007
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00487734 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by McGuire Research Institute:

Metabolic Syndrome
Hypogonadism
Insulin Resistance

Additional relevant MeSH terms:

Metabolic Diseases
Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones
Pharmacologic Actions
Insulin

Testosterone 17 beta-cypionate
Hyperinsulinism
Anabolic Agents
Testosterone
Hypoglycemic Agents
Hypogonadism
Pathologic Processes
Therapeutic Uses
Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Androgens

ClinicalTrials.gov processed this record on February 09, 2010