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CompletedNCT00738114Updated Nov 21, 2013

Diabetes in the Perioperative Period

An observational study in Hyperglycemia and Diabetes, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-21.

Sponsored by Emory University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,184
Ages
18 Years and older
Sex
All
01

Study 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 (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.

02

Conditions studied

  • Hyperglycemia
  • Diabetes

Keywords

  • non-cardiac
  • surgery
  • mortality
  • morbidity
  • perioperative
  • period
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 3,184 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.

Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

all patients admitted for non-cardiac surgery during the period of 01/01/07 and 06/30/2007

Inclusion criteria

  • patient undergoing non-cardiac surgery (inpatient only)

Exclusion criteria

Exclusion Criteria:

  • outpatient procedures, cardiac surgery
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,184 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Emory Universiy Hospital
    Atlanta, Georgia 30322, United States
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00738114
Lead sponsor
Emory University
Responsible party
Guillermo Umpierrez (Principal Investigator, Emory University) — Principal investigator
First posted
Aug 20, 2008
Start date
Aug 2008
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Nov 21, 2013

Study contacts

Guillermo Umpierrez, MD
principal investigator · Emory University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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