Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer

Massachusetts General Hospital60 enrolled

Overview

The purpose of this study is to find out if androgen deprivation therapy affects insulin, cardiac risk factors such as cholesterol level, and body fat and muscle.

* This is a non-treatment study. This study has no effect on the care the participant will receive. * In addition to the participants routine standard medical appointments they will need to make 2 additional outpatient visits for special testing over 12 weeks. These 2 additional outpatient visits will include the following: 1) urine and blood tests, 2) Oral Glucose Tolerance Test (OGTT) 3) Body measurements with a tape measure of your arms, legs, and waist and 4) x-ray evaluations (CT scan and bone density test).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Prostate Cancer

Interventions

Androgen deprivation therapyDRUG

According to standard medical care

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adenocarcinoma of the prostate, clinical stage M0 * About to initiate GnRH agonist therapy * Karnofsky Performance Status 90 or 100 * Serum creatinine \< 2.0mg/dl Exclusion Criteria: * Hormone therapy within 12 months * History of diabetes mellitus or glucose intolerance * Anabolic agents or metabolic agents known to affect insulin or glucose levels * Prior hormone therapy within the past 12 months and planned hormone therapy during the 12 week study (Group 2)

Locations (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

insulin sensitity

Time frame: 12 weeks

Data from ClinicalTrials.gov

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