Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors
1 other identifier
interventional
15
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
Started Sep 2007
Typical duration for phase_2 prostate-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedJuly 11, 2013
July 1, 2013
5 years
June 23, 2008
July 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the effect of intensive lifestyle modification on insulin sensitivity in men receiving GnRH agonist therapy for prostate cancer.
1 year
Secondary Outcomes (1)
To evaluate the effects of intensive lifestyle modification on other markers of cardiovascular disease risk.
1 year
Study Arms (2)
A
EXPERIMENTALIntensive lifestyle intervention based on the Diabetes Prevention Program
B
NO INTERVENTIONWill follow the guidelines for healthy living established by the Food Guide Pyramid and the National Cholesterol Education Program
Interventions
12-lesson program which will cover diet, exercise, and behavior modification.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Smith, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
June 23, 2008
First Posted
August 20, 2008
Study Start
September 1, 2007
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
July 11, 2013
Record last verified: 2013-07