Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors
NCT ID: NCT00738140
Last Updated: 2013-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
15 participants
INTERVENTIONAL
2007-09-30
2012-09-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A
Intensive lifestyle intervention based on the Diabetes Prevention Program
Diabetes Prevention Program
12-lesson program which will cover diet, exercise, and behavior modification.
B
Will follow the guidelines for healthy living established by the Food Guide Pyramid and the National Cholesterol Education Program
No interventions assigned to this group
Interventions
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Diabetes Prevention Program
12-lesson program which will cover diet, exercise, and behavior modification.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Matthew R. Smith, MD, PhD
Professor of Medicine
Principal Investigators
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Matthew Smith, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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Other Identifiers
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07-081
Identifier Type: -
Identifier Source: org_study_id
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