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

Mass General Brigham

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Behavioral: Diabetes Prevention Program

Study type

Interventional

Funder types

Other

Identifiers

NCT00738140

07-081

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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