Pre-diabetesNCT00589459
Gender Differences in Prevalence of Undiagnosed Diabetes in ACS
An observational study of Pre-diabetes and Diabetes, run by Yale University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Pre-diabetes, Diabetes
- How many people
- 103 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2001to 1 Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Women and men admitted with an acute coronary syndrome who do not have a prior diagnosis of diabetes
Who may be able to join
- acute coronary syndrome
- age > 30 yrs
Who cannot join
- previously diagnosed diabetes
- ACS due to substance abuse or trauma
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Yale Center for Clinical Investigation
New Haven, Connecticut, 06520
About this study
Official title: 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.
- Conditions
- Pre-diabetes, Diabetes
- Keywords
- undiagnosed diabetes, undiagnosed pre-diabetes, acute coronary syndrome, undiagnosed pre-diabetes and undiagnosed diabetes
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | non-diabetic women with acute coronary syndrome (ACS) | |
| 2 | non-diabetic men with acute coronary syndrome (ACS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of undiagnosed pre-diabetes or undiagnosed diabetes
Measured: after hospitalization for acute coronary syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study start1 Oct 2001
- Primary completion1 Sep 2005
- Study completion1 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-diabetesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Ethel F Donaghue Women's Health Investigator's Program at Yale
- Investigators
- Barbara I Gulanski, MD, MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589459
- Sponsor's protocol ID
- 12258
- Other IDs
- AHA, Donaghue Women's Health R02524
- Status last verified
- Aug 2023
- First submitted
- 27 Dec 2007
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Gender Differences in the Prevalence of Undiagnosed Diabetes in Acute Coronary Syndromes (ACS)
- ClinicalTrials.gov ID
- NCT00589459
- Acronym / sponsor ID
- 12258
- Conditions
- Pre-diabetes, Diabetes
- Keywords
- undiagnosed diabetes, undiagnosed pre-diabetes, acute coronary syndrome, undiagnosed pre-diabetes and undiagnosed diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, Ethel F Donaghue Women's Health Investigator's Program at Yale
- Study start
- 1 Oct 2001 (actual)
- Primary completion
- 1 Sep 2005 (actual)
- Study completion
- 1 Dec 2008 (actual)
- First posted
- 9 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –non-diabetic women with acute coronary syndrome (ACS) |
| 2 | – | –non-diabetic men with acute coronary syndrome (ACS) |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women and men admitted with an acute coronary syndrome who do not have a prior diagnosis of diabetes
Key inclusion criteria (2 listed)
- acute coronary syndrome
- age > 30 yrs
Key exclusion criteria (2 listed)
- previously diagnosed diabetes
- ACS due to substance abuse or trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of undiagnosed pre-diabetes or undiagnosed diabetes
Time frame: after hospitalization for acute coronary syndrome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara I Gulanski, MD, MPH principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-diabetes and Diabetes, run by Yale University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of undiagnosed pre-diabetes or undiagnosed diabetes (time frame: after hospitalization for acute coronary syndrome). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.