Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors - Full Text View

Sponsors and Collaborators:	Massachusetts General Hospital Lance Armstrong Foundation
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00738140

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Behavioral: Diabetes Prevention Program	Phase II

MedlinePlus related topics: Cancer Diabetes Diets Prostate Cancer

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To evaluate the effect of intensive lifestyle modification on insulin sensitivity in men receiving GnRH agonist therapy for prostate cancer. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the effects of intensive lifestyle modification on other markers of cardiovascular disease risk. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Intensive lifestyle intervention based on the Diabetes Prevention Program	Behavioral: Diabetes Prevention Program 12-lesson program which will cover diet, exercise, and behavior modification.
B: No Intervention Will follow the guidelines for healthy living established by the Food Guide Pyramid and the National Cholesterol Education Program

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738140

Contacts

Contact: Matthew R Smith, MD, PhD	617-724-5257
Contact: Carol Gurski, RN	617-643-1770

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Matthw R Smith, MD, PhD
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Mary Ellen Taplin, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Glen Bubley, MD

Sponsors and Collaborators

Massachusetts General Hospital

Lance Armstrong Foundation

Investigators

Principal Investigator:

Matthew Smith, MD, PhD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Massachusetts General Hospital ( Matthew R Smith, MD, PhD )
Study ID Numbers:	07-081
Study First Received:	June 23, 2008
Last Updated:	April 2, 2009
ClinicalTrials.gov Identifier:	NCT00738140 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

insulin sensitivity
Diabetes Prevention Program
lifestyle intervention

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Diabetes Mellitus
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Insulin

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009