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

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 Prostate Cancer

ChemIDplus related topics:

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 2009
Estimated Primary Completion Date:	September 2009 (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 Smith, MD	617-724-5257

Contact: David Romano	617-726-3445

Locations


United States, Massachusetts
	Massachusetts General Hospital	Recruiting
	Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Lance Armstrong Foundation

Investigators


Principal Investigator:	Matthew Smith, MD, PhD	Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Matthew Smith, MD, PhD )
Study ID Numbers:	07-081
First Received:	June 23, 2008
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00738140
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

ClinicalTrials.gov processed this record on October 15, 2008

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