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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738140
• Other study ID #: 07-081
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2008
• Last updated: July 9, 2013
• Start date: September 2007
• Est. completion date: September 2012

Study information

• Verified date: July 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Diabetes Prevention Program
12-lesson program which will cover diet, exercise, and behavior modification.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of intensive lifestyle modification on insulin sensitivity in men receiving GnRH agonist therapy for prostate cancer.		1 year	No
Secondary	To evaluate the effects of intensive lifestyle modification on other markers of cardiovascular disease risk.		1 year	No