Stress HyperglycemiaNCT02068989
Study of Stress Hyperglycemia as an Indicator of Diabetes Mellitus
An observational study of Stress Hyperglycemia and Diabetes Mellitus Type 2, run by Yale University at 2 sites in United States.
Trial summary
We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2 diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood glucose readings reviewed during their intensive care unit stay. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stress Hyperglycemia, Diabetes Mellitus Type 2
- How many people
- 1 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Mar 2015
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive Care Unit admissions who are not known to be diabetic
Who may be able to join
- All patients admitted to the intensive care unit at the Yale New Haven Hospital St. Raphael Campus and Norwalk Hospital
Who cannot join
- Patients with prior history of diabetes mellitus
- Elevated admission HbA1c (≥6.5%)
- Age >80 years
- Metastatic disease with expected life expectancy of less than 12 months
- Pregnancy or a woman who plans to become pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Hospital St. Raphael Campus
New Haven, Connecticut, 06511
Norwalk Hospital
Norwalk, Connecticut, 06850
About this study
Official title: Stress Hyperglycemia as an Indicator for Future Diabetes Mellitus: A Prospective Cohort Study
We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2 diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood glucose readings reviewed during their intensive care unit stay. All subjects are consented and have a HbA1C level drawn to determine if they have diabetes mellitus or not. They are then followed up in 1 year and the HbA1C repeated to determine if they have developed diabetes mellitus over the course.
- Conditions
- Stress Hyperglycemia, Diabetes Mellitus Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2
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 |
|---|---|---|
| Stress Hyperglycemic Group | Repeat HbA1C in 1 year | |
| Euglycemic Group | Repeat HbA1C in 1 year |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects with an HbA1c greater than or equal to 6.5%
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress HyperglycemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Atlas, MD, Principal investigator, Yale New Haven HospitalJonathon Fine, MD, Principal investigator, Norwalk Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068989
- Sponsor's protocol ID
- 1301011408
- Status last verified
- Sep 2016
- First submitted
- 19 Feb 2014
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Hyperglycemia as an Indicator for Future Diabetes Mellitus: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02068989
- Acronym / sponsor ID
- 1301011408
- Conditions
- Stress Hyperglycemia, Diabetes Mellitus Type 2
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 21 Feb 2014 (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.
We hypothesize that stress hyperglycemia is an indicator that a patient will develop type 2 diabetes mellitus in the future. Subjects who are not diabetic are enrolled and blood glucose readings reviewed during their intensive care unit stay. All subjects are consented and have a HbA1C level drawn to determine if they have diabetes mellitus or not. They are then followed up in 1 year and the HbA1C repeated to determine if they have developed diabetes mellitus over the course.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Hyperglycemic Group | – | –Repeat HbA1C in 1 year |
| Euglycemic Group | – | –Repeat HbA1C in 1 year |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive Care Unit admissions who are not known to be diabetic
Key inclusion criteria (1 listed)
- All patients admitted to the intensive care unit at the Yale New Haven Hospital St. Raphael Campus and Norwalk Hospital
Key exclusion criteria (5 listed)
- Patients with prior history of diabetes mellitus
- Elevated admission HbA1c (≥6.5%)
- Age >80 years
- Metastatic disease with expected life expectancy of less than 12 months
- Pregnancy or a woman who plans to become pregnant
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
Percentage of Subjects with an HbA1c greater than or equal to 6.5%
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
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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.
Stephen Atlas, MD principal investigator
Yale New Haven Hospital
Jonathon Fine, MD principal investigator
Norwalk Hospital
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 Stress Hyperglycemia and Diabetes Mellitus Type 2, 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 Sep 2016. 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 was stopped early. Results are not available in the source record.
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?
Percentage of Subjects with an HbA1c greater than or equal to 6.5% (time frame: 1 year). 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 5 Sep 2016.