C-Reactive Protein and Endothelial Dysfunction in Women With Glucose Intolerance

This study is ongoing, but not recruiting participants.

First Received: December 27, 2007 No Changes Posted

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00589355

Purpose

The goal of this study is to determine whether markers of vascular inflammation (such as c-reactive protein) can predict endothelial dysfunction (as measured by flow-mediated dilation) in postmenopausal women with glucose intolerance compared to normal controls.

Condition
Glucose Intolerance

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Cross-Sectional
Official Title:	C-Reactive Protein and Endothelial Dysfunction in Women With Glucose Intolerance

Further study details as provided by Yale University:

Primary Outcome Measures:

c-reactive protein [ Time Frame: performed after screening evaluation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

flow-mediated dilation of brachial artery [ Time Frame: performed twice after screening visit ] [ Designated as safety issue: No ]
sex steroids [ Time Frame: performed after screening visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	46
Study Start Date:	January 2002
Estimated Study Completion Date:	October 2008
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 postmenopausal women with glucose intolerance (either pre-diabetes or diet-controlled diabetes)
2 postmenopausal women with normal glucose tolerance

Eligibility

Ages Eligible for Study:	40 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Two groups of healthy postmenopausal women who do not smoke. One group includes women with either pre-diabetes or diet-controlled diabetes. The control group includes women with normal glucose tolerance

Criteria

Inclusion Criteria:

healthy postmenopausal women
ages 40-65

Exclusion Criteria:

smokers
diabetes requiring medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589355

Locations

United States, Connecticut
Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Barbara I Gulanski, MD, MPH

Yale University

More Information

No publications provided

Responsible Party:	Yale University School of Medicine ( Barbara I Gulanski, MD, MPH )
Study ID Numbers:	12110
Study First Received:	December 27, 2007
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00589355 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

c-reactive protein
endothelial dysfunction
glucose intolerance

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Hyperglycemia
Glucose Intolerance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009