Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors

Prostate Cancer Clinical Trial

Official title: Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors

Status Completed

Clinical Trial 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 and other cardiovascular disease, in men receiving GnRH hormone therapy for prostate cancer.

Clinical Trial 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 other (Control Group) will follow the guidelines for healthy living established by the Food Guide Pyramid and the National Cholesterol Education Program.

• All visits will take place at the General Clinical Research Center at the Massachusetts General Hospital.

• 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00738140
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: Phase 2
• Start date: September 2007
• Completion date: September 2012