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Completed

NCT Number: NCT00455624

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

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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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Male Urogenital Diseases Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Androgen Deprivation Therapy

Drug

According to standard medical care

Primary outcomes

  1. insulin sensitity

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute

Registry information

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Apr 4, 2007
Registry last updated
Jul 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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