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


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


- 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).


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)

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

insulin sensitity

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Matthew Smith, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Institutional Review Board

Study ID:

02-256

NCT ID:

NCT00455624

Start Date:

November 2002

Completion Date:

May 2006

Related Keywords:

  • Prostate Cancer
  • androgen deprivation therapy
  • insulin resistance
  • Cardiovascular Diseases
  • Insulin Resistance
  • Prostatic Neoplasms

Name

Location

Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617