Gender Differences in Prevalence of Undiagnosed Diabetes in ACS

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:
Collaborators:
American Heart Association
Ethel F Donaghue Women's Health Investigator's Program at Yale
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00589459
First received: December 27, 2007
Last updated: January 8, 2008
Last verified: December 2007
  Purpose

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.


Condition
Pre-Diabetes
Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Pilot Study of Gender Differences in the Prevalence of Undiagnosed Diabetes in Acute Coronary Syndromes (ACS)

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Prevalence of undiagnosed pre-diabetes or undiagnosed diabetes [ Time Frame: after hospitalization for acute coronary syndrome ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: October 2001
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
non-diabetic women with acute coronary syndrome (ACS)
2
non-diabetic men with acute coronary syndrome (ACS)

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

  • acute coronary syndrome
  • age > 30 yrs

Exclusion Criteria:

  • previously diagnosed diabetes
  • ACS due to substance abuse or trauma
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589459

Locations
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
American Heart Association
Ethel F Donaghue Women's Health Investigator's Program at Yale
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: NCT00589459     History of Changes
Other Study ID Numbers: 12258, AHA, Donaghue Women's Health R02524
Study First Received: December 27, 2007
Last Updated: January 8, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
undiagnosed diabetes
undiagnosed pre-diabetes
acute coronary syndrome
undiagnosed pre-diabetes and undiagnosed diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Acute Coronary Syndrome
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 10, 2014