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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00738140

Run by

Massachusetts General Hospital

People needed

15

Starts

2007-09-01

Expected to finish

2012-09-01

Last updated by the study team

2013-07-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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