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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Yale University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00589355
First received: December 27, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  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

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

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 ]

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

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

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

ClinicalTrials.gov processed this record on May 23, 2013