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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2007 by Yale University.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00589355
First Posted: January 9, 2008
Last Update Posted: January 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yale University
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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 ]

Secondary Outcome Measures:
  • flow-mediated dilation of brachial artery [ Time Frame: performed twice after screening visit ]
  • sex steroids [ Time Frame: performed after screening visit ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Barbara I Gulanski, MD, MPH, Yale University School of Medicine
ClinicalTrials.gov Identifier: NCT00589355     History of Changes
Other Study ID Numbers: 12110
First Submitted: December 27, 2007
First Posted: January 9, 2008
Last Update Posted: January 9, 2008
Last Verified: December 2007

Keywords provided by Yale University:
c-reactive protein
endothelial dysfunction
glucose intolerance

Additional relevant MeSH terms:
Glucose Intolerance
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases