Lifestyle Intervention to Improve Insulin Sensitivity and... | NCT00738140

Studies
Lifestyle Intervention to Improve Insulin Sensitivity and Markers of Cardiovascular Risk in Prostate Cancer Survivors

NCT00738140

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jul 11, 2013Estimated

Enrollment

15Actual

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

Diabetes Prevention Program

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

Sep 2007

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jun 23, 2008

First Submission Date that Met QC Criteria

Aug 19, 2008

First Posted Date

Aug 20, 2008Estimated

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

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 discover if intensive lifestyle changes (such as diet and increased physical activity) improve the body's sensitivity to insulin, and therefore help prevent diabetes and other cardiovascular disease, in men receiving GnRH hormone therapy for prostate cancer.

Detailed Description

In this study, participants will be divided into two groups. One group will undergo intensive lifestyle changes (Lifestyle Intervention Group) designed by the Diabetes Prevention Group, and the other (Control Group) will follow the guidelines for healthy living established by the Food Guide Pyramid and the National Cholesterol Education Program.
All visits will take place at the General Clinical Research Center at the Massachusetts General Hospital.
At the initial visit, the following will be performed: Bionutrition evaluation; Oral Glucose Tolerance Test (OGTT); additional blood work and; Dual Energy X-Ray Absorptiometry (DXA) Scan.
After the initial visit, visits will be scheduled at 3, 6 and 12 months after and the above procedures will be repeated.
Participants will be randomized into one of the two study groups. Lifestyle Intervention Group: The goal for participants assigned to this group are to achieve and maintain a weight loss of at least 7% of initial body weight through a healthy low calorie, low fat diet and to engage in physical activity of moderate intensity. Control Group: participants in this group will receive standard nutrition and exercise recommendations from the Food Guide Pyramid and the National Cholesterol Education Program Step 1 diet to reduce body weight and increase physical activity.

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Intensive lifestyle intervention based on the Diabetes Prevention Program	Behavioral: Diabetes Prevention Program
B	No Intervention	Will follow the guidelines for healthy living established by the Food Guide Pyramid and the National Cholesterol Education Program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diabetes Prevention Program	Behavioral	12-lesson program which will cover diet, exercise, and behavior modification.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the effect of intensive lifestyle modification on insulin sensitivity in men receiving GnRH agonist therapy for prostate cancer.		1 year

Secondary Outcomes

Measure	Description	Time Frame
To evaluate the effects of intensive lifestyle modification on other markers of cardiovascular disease risk.		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed prostate cancer
Current Hormone therapy with GnRH agonist of 3 months or longer
Overweight or obese (body mass index of 25kg/m2 or greater)
No other conditions that prevent intensive lifestyle intervention

Exclusion Criteria:

History of diabetes mellitus requiring drug therapy
Hemoglobin Aic of 7% or greater
Symptomatic metastatic disease
Myocardial infarction within 6 months
Treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels
Disease progression according to PSA Working Group Criteria

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

Not provided

Sampling Method

Not provided

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
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Beth Israel Deaconess Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms
D007333	Insulin Resistance

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided