Back to resultsEffect of Testosterone Replacement on Insulin Resistance
Primary Purpose
Metabolic Syndrome, Hypogonadism
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Testosterone gel
Placebo for testosterone gel
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, Hypogonadism, Insulin Resistance
Eligibility Criteria
Inclusion Criteria: (subjects must meet both criteria)
Metabolic syndrome (have 3 out of the following 4 criteria):
- BP > 130/85 or on antihypertensive therapy
- Fasting glucose > 100 mg/dl
- 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)
- 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:
- Creatinine greater than 1.4 mg/dl
- Triglyceride levels greater than 500 mg/dl
- HDL-C levels less than 20 mg/dl
- Blood pressure greater than 160/90
The following men will be excluded because of the potential side effects of testosterone therapy:
- Men greater than 65 years of age
- International prostate symptom score >19
- PSA greater than 2.5
- History of benign prostatic hypertrophy
- History of prostate cancer
- Abnormal digital rectal exam
- Hg greater than 16 mg/dl or Hct greater than 48%
- peripheral edema
Sites / Locations
- Hunter Holmes McGuire VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Subjects in this arm will receive testosterone gel
Outcomes
Primary Outcome Measures
Change in insulin sensitivity as measured by HOMA-IR
Secondary Outcome Measures
Changes in parameters of the Metabolic Syndrome
Changes in body composition
Changes in total and high MW adiponectin levels
Full Information
NCT ID
NCT00487734
First Posted
June 15, 2007
Last Updated
October 22, 2012
Sponsor
McGuire Research Institute
Collaborators
Solvay Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00487734
Brief Title
Effect of Testosterone Replacement on Insulin Resistance
Official Title
Effect of Testosterone Replacement on Insulin Resistance in Hypogonadal, Non-obese Men With Metabolic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McGuire Research Institute
Collaborators
Solvay Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Hypogonadism
Keywords
Metabolic Syndrome, Hypogonadism, Insulin Resistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Subjects in this arm will receive testosterone gel
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Radiation
Intervention Name(s)
Testosterone gel
Other Intervention Name(s)
Androgel
Intervention Description
testosterone gel, applied daily. Dosed to achieve testosterone level <500 ng/dL. Possible doses include 2.5g, 5g, 7.5g or 10g gel packets.
Intervention Type
Drug
Intervention Name(s)
Placebo for testosterone gel
Intervention Description
Placebo gel, 2.5g for each gel packet
Primary Outcome Measure Information:
Title
Change in insulin sensitivity as measured by HOMA-IR
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Changes in parameters of the Metabolic Syndrome
Time Frame
18 weeks
Title
Changes in body composition
Time Frame
18 weeks
Title
Changes in total and high MW adiponectin levels
Time Frame
18 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (subjects must meet both criteria)
Metabolic syndrome (have 3 out of the following 4 criteria):
BP > 130/85 or on antihypertensive therapy
Fasting glucose > 100 mg/dl
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)
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:
Creatinine greater than 1.4 mg/dl
Triglyceride levels greater than 500 mg/dl
HDL-C levels less than 20 mg/dl
Blood pressure greater than 160/90
The following men will be excluded because of the potential side effects of testosterone therapy:
Men greater than 65 years of age
International prostate symptom score >19
PSA greater than 2.5
History of benign prostatic hypertrophy
History of prostate cancer
Abnormal digital rectal exam
Hg greater than 16 mg/dl or Hct greater than 48%
peripheral edema
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja K Fredrickson, MD
Organizational Affiliation
Hunter Holmes McGuire VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
12. IPD Sharing Statement
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Effect of Testosterone Replacement on Insulin Resistance
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