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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00738140
First received: June 23, 2008
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 15
Study Start Date: September 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Intensive lifestyle intervention based on the Diabetes Prevention Program
 Behavioral: Diabetes Prevention Program
12-lesson program which will cover diet, exercise, and behavior modification.
No Intervention: B
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

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Matthew Smith, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00738140     History of Changes
Other Study ID Numbers: 07-081
Study First Received: June 23, 2008
Last Updated: January 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
insulin sensitivity
Diabetes Prevention Program
lifestyle intervention

Additional relevant MeSH terms:
Prostatic Neoplasms
Insulin Resistance
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013