Status:
TERMINATED
Effect of Increasing Testosterone on Insulin Sensitivity in Men With the Metabolic Syndrome
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
American Diabetes Association
Conditions:
Metabolic Syndrome
Eligibility:
MALE
50-75 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to examine the effect of testosterone treatment on insulin in men with the metabolic syndrome with testosterone levels at or below the lower end of the normal range.
Detailed Description
The metabolic syndrome is a medical condition defined by high cholesterol levels, high blood pressure, increased abdominal obesity (gain in fat around the region of the stomach), and insulin resistanc...
Eligibility Criteria
Inclusion
- Stable weight for previous three months (no weight change greater than or equal to +/-10 lbs)
Exclusion
- No new diagnosis of type 2 diabetes or on oral hypoglycemic agents
- No history of testicular disorders
- No history of bleeding disorders (i.e. Pulmonary Embolism, Deep Vein Thrombosis, stroke, hypercoagulable syndrome)
- No history of prostate cancer
- No previous diagnosis of osteoporosis
- No history of sleep apnea (subjects will also be excluded if at their baseline assessment they admit to heavy snoring, restless sleep, and/or excessive daytime somnolence)
- No symptoms of urinary outflow obstruction or medications for prostate disease
- No illicit drug use or heavy alcohol use (\>4 drinks/day)
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2010
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00438321
Start Date
September 1 2006
End Date
February 26 2010
Last Update
April 18 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114