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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00455624
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Prostate Cancer Drug: Androgen deprivation therapy

Detailed Description:
  • 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 Design

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Study of Insulin Resistance and Cardiovascular Disease Risk During Androgen Deprivation Therapy for Prostate Cancer
Study Start Date : November 2002
Primary Completion Date : May 2006
Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Insulin
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Drug: Androgen deprivation therapy
    According to standard medical care

Outcome Measures

Primary Outcome Measures :
  1. insulin sensitity [ Time Frame: 12 weeks ]

Biospecimen Retention:   Samples With DNA
Whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men identified with prostate cancer.

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455624

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Matthew Smith, MD, PhD Massachusetts General Hospital
More Information

Responsible Party: Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00455624     History of Changes
Other Study ID Numbers: 02-256
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Matthew R. Smith, MD, PhD, Massachusetts General Hospital:
androgen deprivation therapy
insulin resistance

Additional relevant MeSH terms:
Prostatic Neoplasms
Cardiovascular Diseases
Insulin Resistance
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Ascorbic Acid
Estrogens, Conjugated (USP)
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Protective Agents
Growth Substances
Antineoplastic Agents, Hormonal
Antineoplastic Agents