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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-11-30

Study Completion Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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* 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).

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Androgen deprivation therapy

According to standard medical care

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No