Status:
TERMINATED
Androgen Deprivation Therapy Study
Lead Sponsor:
National Institute on Aging (NIA)
Conditions:
Hypogonadism
Metabolic Syndrome
Eligibility:
MALE
18+ years
Brief Summary
The purpose of this study is to examine the link between low testosterone and insulin resistance/diabetes in men undergoing androgen deprivation therapy for prostate cancer. The study will also evalua...
Detailed Description
Lowering of testosterone levels, by medications or surgery (Androgen Deprivation Therapy or ADT), is commonly used in the treatment of prostate cancer. The adverse effects of low testosterone include ...
Eligibility Criteria
Inclusion
- Men 18 years of age or older with prostate cancer
- Planning to undergo long-term (at least 12 months) ADT
- No known history of diabetes
- No history of ADT
Exclusion
- History of ADT or any prior diagnosis of hypogonadism
- Fasting glucose or oral glucose tolerance test results in the diabetic range
- Heart failure (NY classification III or IV)
- Testosterone level less than 250 ng/dl on screening
- History of heart attack or open-heart surgery within the past 6 months
- Use of steroids within the past 3 months, including prednisone, cortisone injections, inhaled steroids (topical steroids are acceptable)
- Use of anabolic steroids (testosterone, DHEA, DHEAS) or any growth promoters (growth hormone itself or analogs of growth hormone) in the past 12 months
- Liver function tests more than 3 times upper normal limits
- Undergoing intermittent ADT
- Uncontrolled thyroid disease (hyper- or hypo-thyroidism)
- Anemia, defined as hematocrit less than 38%
- Not physically capable of completing the tests
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00743327
Start Date
October 1 2008
End Date
August 1 2012
Last Update
August 6 2012
Active Locations (1)
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1
NIA Clinical Research Unit located at Harbor Hospital
Baltimore, Maryland, United States, 21225