Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery
Completed · Phase 3
Conditions studied: Diabetes Mellitus, Cardiovascular Diseases
In brief
Preliminary studies have shown that people with diabetes who undergo heart surgery may have a higher risk of developing cognitive functioning problems, including memory problems, than people without diabetes who undergo heart surgery. Among people with diabetes, however, those who control their blood sugar levels in a more intensive way during and after heart surgery may have better neurological outcomes than those who use a standard method of controlling their blood sugar levels. This study will compare the effectiveness of using a traditional method of blood sugar control versus a more intensive method of blood sugar control during and after heart surgery for improving neurological outcomes in people with diabetes.
Key facts
- Study ID
- NCT00836329
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 133
- Starts
- 2008-12-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2016-07-12
Who can join
Age: 35 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- History of diabetes, elevated fasting blood glucose, elevated hemoglobin A1c, or elevation of these variables during the current hospital admission
- Scheduled to undergo coronary artery bypass graft (CABG) surgery
- Scheduled to undergo aortic valve replacement (AVR), mitral valve replacement (MVR), or both
- Scheduled to undergo valve replacement with CABG
You may not qualify if…
- Undergoing emergent (i.e., urgent) procedures
- Alzheimer's disease or similar dementias
- Severe claustrophobia
- Kidney insufficiency, as defined by serum creatine levels greater than 2.0 mg/dL
- Cannot be expected to complete neuropsychological testing
- Recent extensive, life threatening acute myocardial infarction (AMI)
Where it is running
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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