Prospective Study of Insulin Resistance and Cardiovascula... | NCT00455624

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

NCT00455624

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jul 11, 2013Estimated

Enrollment

60Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Androgen deprivation therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2002

Primary Completion Date

May 2006Actual

Completion Date

May 2006Actual

First Submitted Date

Apr 2, 2007

First Submission Date that Met QC Criteria

Apr 2, 2007

First Posted Date

Apr 4, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2013

Last Update Posted Date

Jul 11, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Dana-Farber Cancer Institute	OTHER
Brigham and Women's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Androgen deprivation therapy	Drug	According to standard medical care

Measure	Description	Time Frame
insulin sensitity		12 weeks

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Men identified with prostate cancer.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matthew Smith, MD, PhD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dana-Farber Cancer Institute		Boston	Massachusetts	02115	United States
Massachusetts General Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16434464	Background	Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24.

ID	Term
D011471	Prostatic Neoplasms
D007333	Insulin Resistance

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D006727	Hormone Antagonists
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions