Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00455624
Recruitment Status :
First Posted : April 4, 2007
Last Update Posted : July 11, 2013
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital
The purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.
Condition or disease
Drug: Androgen deprivation therapy
This is a non-treatment study. This study has no effect on the care the participant will receive.
In addition to the participants routine standard medical appointments they will need to make 2 additional outpatient visits for special testing over 12 weeks. These 2 additional outpatient visits will include the following: 1) urine and blood tests, 2) Oral Glucose Tolerance Test (OGTT) 3) Body measurements with a tape measure of your arms, legs, and waist and 4) x-ray evaluations (CT scan and bone density test).
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Men identified with prostate cancer.
Adenocarcinoma of the prostate, clinical stage M0
About to initiate GnRH agonist therapy
Karnofsky Performance Status 90 or 100
Serum creatinine < 2.0mg/dl
Hormone therapy within 12 months
History of diabetes mellitus or glucose intolerance
Anabolic agents or metabolic agents known to affect insulin or glucose levels
Prior hormone therapy within the past 12 months and planned hormone therapy during the 12 week study (Group 2)