Impact of Diet and/or Exercise-induced Weight Loss on Car... | NCT00588978

Studies
Impact of Diet and/or Exercise-induced Weight Loss on Cardiovascular Risk Factors

NCT00588978

Sponsor

Yale University

Status

Completed

Last Update Posted

Apr 17, 2020Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Cardiovascular Diseases

Interventions

diet and/or exercise

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

Apr 2020

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

Aug 1, 2003Actual

Primary Completion Date

Feb 1, 2007Actual

Completion Date

Dec 1, 2008Actual

First Submitted Date

Dec 27, 2007

First Submission Date that Met QC Criteria

Jan 8, 2008

First Posted Date

Jan 9, 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

Apr 16, 2020

Last Update Posted Date

Apr 17, 2020Actual

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 pilot study is to examine the effect of diet and/or exercise-induced weight loss on nontraditional cardiovascular risk factors such as c-reactive protein, insulin levels and sex steroids in obese postmenopausal women.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Diet alone	Behavioral: diet and/or exercise
2	Active Comparator	Exercise alone	Behavioral: diet and/or exercise
3	Active Comparator	Diet and exercise (combined)	Behavioral: diet and/or exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
diet and/or exercise	Behavioral	Three arms are included: Diet Alone, Exercise Alone, and Combined Diet and Exercise	1 2 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
c-reactive protein		baseline, every 1-2 weeks during intervention , then end-of-study

Secondary Outcomes

Measure	Description	Time Frame
HOMA (measure of insulin resistance) and sex steroids		baseline, every 1-2 weeks during intervention, then end-of-study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

obese postmenopausal women
able to exercise
non-smokers

Exclusion Criteria:

cardiovascular disease
medications that would interfere with outcome measures (e.g., including ACE inhibitors, lipid lowering medications, beta-blockers, etc)
known diabetes

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara I Gulanski, MD, MPH	Yale Univeristy School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yale Center for Clinical Investigation		New Haven	Connecticut	06520	United States

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided