Gender Differences in Prevalence of Undiagnosed Diabetes... | NCT00589459

Studies
Gender Differences in Prevalence of Undiagnosed Diabetes in ACS

NCT00589459

Sponsor

Yale University

Status

Completed

Last Update Posted

Aug 30, 2023Actual

Enrollment

103Actual

Phase

Not provided

Conditions

Pre-diabetes
Diabetes

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2001Actual

Primary Completion Date

Sep 1, 2005Actual

Completion Date

Dec 1, 2008Actual

First Submitted Date

Dec 27, 2007

First Submission Date that Met QC Criteria

Jan 8, 2008

First Posted Date

Jan 9, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2023

Last Update Posted Date

Aug 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Yale UniversityOTHER

Collaborators

Name	Class
American Heart Association	OTHER
Ethel F Donaghue Women's Health Investigator's Program at Yale	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		non-diabetic women with acute coronary syndrome (ACS)
2		non-diabetic men with acute coronary syndrome (ACS)

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

acute coronary syndrome
age > 30 yrs

Exclusion Criteria:

previously diagnosed diabetes
ACS due to substance abuse or trauma

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara I Gulanski, MD, MPH	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bridgeport Hospital		Bridgeport	Connecticut	06610	United States
Yale Center for Clinical Investigation

Condition Browse Module

MeSH Terms

ID	Term
D018149	Glucose Intolerance
D003920	Diabetes Mellitus
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D006943	Hyperglycemia
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided