HyperglycemiaNCT00738114
Diabetes in the Perioperative Period
An observational study of Hyperglycemia and Diabetes, run by Emory University at 1 site in United States.
Trial summary
High blood glucose levels in surgical patients with and without diabetes are associated with increased risk of medical complications and death. Over the short-term, high blood glucose can adversely affect fluid balance, impair immunologic response to infection, and promote inflammation and endothelial dysfunction… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Diabetes
- How many people
- 3,184 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients admitted for non-cardiac surgery during the period of 01/01/07 and 06/30/2007
Who may be able to join
- patient undergoing non-cardiac surgery (inpatient only)
Who cannot join
- outpatient procedures, cardiac surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome
High blood glucose levels in surgical patients with and without diabetes are associated with increased risk of medical complications and death. Over the short-term, high blood glucose can adversely affect fluid balance, impair immunologic response to infection, and promote inflammation and endothelial dysfunction (blood vessel function). Blood glucose control with intensive insulin therapy in patients with critical illness (very sick patients in intensive care unit) reduces the risk of multiorgan failure and systemic infections, and decreases short- and long-term mortality. High blood glucose has also been associated with poor outcome in non-critically ill patients admitted to general surgical and medical wards; however, intensive glycemic control is not aggressively pursued because of fear of hypoglycemia. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2008 provided very little information on the prevalence and outcome of high blood glucose during the perioperative period (before and after surgery) in non-critically ill patients. Therefore, the present study aims to evaluate the impact of high blood glucose, in large number of subjects with and without diabetes, during general (non-cardiac) surgery.
Read the detailed description
We will perform a retrospective chart review of all patients who underwent non-cardiac surgery from 01/01/07 to 06/30/07 at Emory University Hospital as inpatient.
- Conditions
- Hyperglycemia, Diabetes
- Keywords
- non-cardiac, surgery, mortality, morbidity, perioperative, period
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
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 | group without hyperglycemia (fasting blood glucose below 126mg/dl) approximately 1000 patients | |
| 2 | group with hyperglycemia (fasting blood glucose above 125 mg/dl) or history of diabetes approximately 500 patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess impact of hyperglycemia and diabetes during the periop period on clinical outcome(mortality and morbidity)in patients undergoing general and non-cardiac surgery.
Measured: 01/01/07 - 06/30/2007
Secondary outcomes (1)
determine the scope of clinical inertia in patients with diabetes and untreated hyperglycemia in patients undergoing non-cardiac surgery
Measured: 01/01/07 - 06/30/2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Emory 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
- Retrospective
- Enrolment
- 3,184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Umpierrez, Emory University
- Investigators
- Guillermo Umpierrez, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738114
- Sponsor's protocol ID
- IRB00011938
- Status last verified
- Nov 2013
- First submitted
- 19 Aug 2008
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Frisch A, Chandra P, Smiley D, Peng L, Rizzo M, Gatcliffe C, Hudson M, Mendoza J, Johnson R, Lin E, Umpierrez GE. Prevalence and clinical outcome of hyperglycemia in the perioperative period in noncardiac surgery. Diabetes Care. 2010 Aug;33(8):1783-8. doi: 10.2337/dc10-0304. Epub 2010 Apr 30.
PubMed 20435798
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes in the Perioperative Period: Prevalence and Clinical Outcome
- ClinicalTrials.gov ID
- NCT00738114
- Acronym / sponsor ID
- IRB00011938
- Conditions
- Hyperglycemia, Diabetes
- Keywords
- non-cardiac, surgery, mortality, morbidity, perioperative, period
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,184 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Aug 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.
High blood glucose levels in surgical patients with and without diabetes are associated with increased risk of medical complications and death. Over the short-term, high blood glucose can adversely affect fluid balance, impair immunologic response to infection, and promote inflammation and endothelial dysfunction (blood vessel function). Blood glucose control with intensive insulin therapy in patients with critical illness (very sick patients in intensive care unit) reduces the risk of multiorgan failure and systemic infections, and decreases short- and long-term mortality. High blood glucose has also been associated with poor outcome in non-critically ill patients admitted to general surgical and medical wards; however, intensive glycemic control is not aggressively pursued because of fear of hypoglycemia. A computerized search of biomedical journal literature from MEDLINE, PubMed, and Ovid from 1966 to 2008 provided very little information on the prevalence and outcome of high blood glucose during the perioperative period (before and after surgery) in non-critically ill patients. Therefore, the present study aims to evaluate the impact of high blood glucose, in large number of subjects with and without diabetes, during general (non-cardiac) surgery.
Detailed description
We will perform a retrospective chart review of all patients who underwent non-cardiac surgery from 01/01/07 to 06/30/07 at Emory University Hospital as inpatient.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –group without hyperglycemia (fasting blood glucose below 126mg/dl) approximately 1000 patients |
| 2 | – | –group with hyperglycemia (fasting blood glucose above 125 mg/dl) or history of diabetes approximately 500 patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients admitted for non-cardiac surgery during the period of 01/01/07 and 06/30/2007
Key inclusion criteria (1 listed)
- patient undergoing non-cardiac surgery (inpatient only)
Key exclusion criteria (1 listed)
- outpatient procedures, cardiac surgery
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
assess impact of hyperglycemia and diabetes during the periop period on clinical outcome(mortality and morbidity)in patients undergoing general and non-cardiac surgery.
Time frame: 01/01/07 - 06/30/2007
1 secondary outcome
determine the scope of clinical inertia in patients with diabetes and untreated hyperglycemia in patients undergoing non-cardiac surgery
Time frame: 01/01/07 - 06/30/2007
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 21 Nov 2013.
- Results publication: PubMed 20435798Frisch A, Chandra P, Smiley D, Peng L, Rizzo M, Gatcliffe C, Hudson M, Mendoza J, Johnson R, Lin E, Umpierrez GE. Prevalence and clinical outcome of hyperglycemia in the perioperative period in noncardiac surgery. Diabetes Care. 2010 Aug;33(8):1783-8. doi: 10.2337/dc10-0304. Epub 2010 Apr 30.
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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.
Guillermo Umpierrez, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Diabetes, run by Emory University at 1 site 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 1 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 21 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
assess impact of hyperglycemia and diabetes during the periop period on clinical outcome(mortality and morbidity)in patients undergoing general and non-cardiac surgery. (time frame: 01/01/07 - 06/30/2007). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00738114, which also lists 1 linked publication.
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 21 Nov 2013.