Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer
- Conditions
- Prostate Cancer
- Registration Number
- NCT00455624
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
* 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method insulin sensitity 12 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States