Status:
COMPLETED
Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to discover if intensive lifestyle changes (such as diet and increased physical activity) improve the body's sensitivity to insulin, and therefore help prevent diabetes an...
Detailed Description
* In this study, participants will be divided into two groups. One group will undergo intensive lifestyle changes (Lifestyle Intervention Group) designed by the Diabetes Prevention Group, and the othe...
Eligibility Criteria
Inclusion
- Histologically confirmed prostate cancer
- Current Hormone therapy with GnRH agonist of 3 months or longer
- Overweight or obese (body mass index of 25kg/m2 or greater)
- No other conditions that prevent intensive lifestyle intervention
Exclusion
- History of diabetes mellitus requiring drug therapy
- Hemoglobin Aic of 7% or greater
- Symptomatic metastatic disease
- Myocardial infarction within 6 months
- Treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels
- Disease progression according to PSA Working Group Criteria
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00738140
Start Date
September 1 2007
End Date
September 1 2012
Last Update
July 11 2013
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115