Gender Differences in Prevalence of Undiagnosed Diabetes in ACS

August 29, 2023 updated by: Yale University

A Pilot Study of Gender Differences in the Prevalence of Undiagnosed Diabetes in Acute Coronary Syndromes (ACS)

The primary goal of this study is to measure the prevalence of undiagnosed pre-diabetes/diabetes among women hospitalized with acute coronary syndromes (ACS) compared to men. Inpatients with confirmed ACS (and no known prior history of diabetes) are invited to return to the Yale Hospital Research Unit 6-8 weeks after hospital discharge for an oral glucose tolerance test to identify individuals with pre-diabetes and diabetes.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

103

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
      • Bridgeport, Connecticut, United States, 06610
        • Bridgeport Hospital
      • 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

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Women and men admitted with an acute coronary syndrome who do not have a prior diagnosis of diabetes

Description

Inclusion Criteria:

  • acute coronary syndrome
  • age > 30 yrs

Exclusion Criteria:

  • previously diagnosed diabetes
  • ACS due to substance abuse or trauma

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
non-diabetic women with acute coronary syndrome (ACS)
2
non-diabetic men with acute coronary syndrome (ACS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of undiagnosed pre-diabetes or undiagnosed diabetes
Time Frame: after hospitalization for acute coronary syndrome
after hospitalization for acute coronary syndrome

Collaborators and Investigators

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

Sponsor

Yale University

Collaborators

American Heart Association
Ethel F Donaghue Women's Health Investigator's Program at Yale

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 (Actual)

October 1, 2001

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 27, 2007

First Submitted That Met QC Criteria

January 8, 2008

First Posted (Estimated)

January 9, 2008

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12258
  • AHA (Other Identifier: American Heart Association)
  • Donaghue Women's Health R02524

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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