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

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Behavioral: Diabetes Prevention Program

• Registration Number: NCT00738140
• Lead Sponsor: Massachusetts General Hospital

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

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 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 Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-09
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Diabetes Prevention Program	Intensive lifestyle intervention based on the Diabetes Prevention Program

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of intensive lifestyle modification on insulin sensitivity in men receiving GnRH agonist therapy for prostate cancer.	1 year

Secondary Outcome Measures

Name	Time	Method
To evaluate the effects of intensive lifestyle modification on other markers of cardiovascular disease risk.	1 year

Trial Locations

Locations (3)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States