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

April 16, 2020 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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

Description

Inclusion Criteria:

  • healthy postmenopausal women
  • ages 40-65

Exclusion Criteria:

  • smokers
  • diabetes requiring medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
c-reactive protein
Time Frame: performed after screening evaluation
performed after screening evaluation

Secondary Outcome Measures

Outcome Measure
Time Frame
flow-mediated dilation of brachial artery
Time Frame: performed twice after screening visit
performed twice after screening visit
sex steroids
Time Frame: performed after screening visit
performed after screening visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Barbara I Gulanski, MD, MPH, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

June 1, 2003

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

December 27, 2007

First Submitted That Met QC Criteria

December 27, 2007

First Posted (Estimate)

January 9, 2008

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12110

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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