Gender Differences in Prevalence of Undiagnosed Diabetes in ACS

This study is ongoing, but not recruiting participants.

First Received: December 27, 2007 Last Updated: January 8, 2008 History of Changes

Sponsors and Collaborators:	Yale University American Heart Association Ethel F Donaghue Women's Health Investigator's Program at Yale
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00589459

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

MedlinePlus related topics: Diabetes

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Locations

United States, Connecticut
Yale Center for Clinical Investigation
New Haven, Connecticut, United States, 06520
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610

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:	Yale University School of Medicine ( Barbara I Gulanski, MD, MPH )
Study ID Numbers:	12258, AHA, Donaghue Women's Health R02524
Study First Received:	December 27, 2007
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00589459 History of Changes
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

Study placed in the following topic categories:

Metabolic Diseases
Heart Diseases
Myocardial Ischemia
Glucose Intolerance
Diabetes Mellitus
Prediabetic State
Vascular Diseases

Endocrine System Diseases
Ischemia
Hyperglycemia
Acute Coronary Syndrome
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Heart Diseases
Hyperglycemia
Metabolic Diseases
Myocardial Ischemia
Acute Coronary Syndrome
Glucose Intolerance

Vascular Diseases
Prediabetic State
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009