Androgen Deprivation Therapy Study

Stopped early

Conditions studied: Hypogonadism, Metabolic Syndrome, Diabetes, Inflammation

In brief

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 evaluate other cardiovascular risk factors in these men.

Key facts

Study ID

NCT00743327

Run by

National Institute on Aging (NIA)

People needed

1

Starts

2008-10-01

Expected to finish

2012-08-01

Last updated by the study team

2012-08-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NIA Clinical Research Unit located at Harbor Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.