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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Male Urogenital Diseases Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diabetes Prevention Program

Behavioral

12-lesson program which will cover diet, exercise, and behavior modification.

Primary outcomes

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

Time frame: 1 year

Secondary outcomes

To evaluate the effects of intensive lifestyle modification on other markers of cardiovascular disease risk.

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Aug 20, 2008
Registry last updated: Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed