Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors
- 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 other (Control Group) will follow the guidelines for healthy
living established by the Food Guide Pyramid and the National Cholesterol Education
- All visits will take place at the General Clinical Research Center at the Massachusetts
- At the initial visit, the following will be performed: Bionutrition evaluation; Oral
Glucose Tolerance Test (OGTT); additional blood work and; Dual Energy X-Ray
Absorptiometry (DXA) Scan.
- After the initial visit, visits will be scheduled at 3, 6 and 12 months after and the
above procedures will be repeated.
- Participants will be randomized into one of the two study groups. Lifestyle
Intervention Group: The goal for participants assigned to this group are to achieve
and maintain a weight loss of at least 7% of initial body weight through a healthy low
calorie, low fat diet and to engage in physical activity of moderate intensity.
Control Group: participants in this group will receive standard nutrition and exercise
recommendations from the Food Guide Pyramid and the National Cholesterol Education
Program Step 1 diet to reduce body weight and increase physical activity.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
To evaluate the effect of intensive lifestyle modification on insulin sensitivity in men receiving GnRH agonist therapy for prostate cancer.
Matthew Smith, MD, PhD
Massachusetts General Hospital
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|