Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 7/13/2016 |
| Start Date: | December 2008 |
| End Date: | May 2014 |
Improving Neurologic Outcomes in Diabetics Undergoing Cardiac Surgery
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.
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.
People with diabetes who undergo heart surgery have a greater risk of experiencing a stroke
and developing cognitive functioning problems than people without diabetes who undergo heart
surgery. There may be a connection between disturbances in glucose metabolism, endothelial
dysfunction, and poor neurological outcomes after heart surgery. People with diabetes who
receive more intensive blood glucose management during and after heart surgery may have
better neurological outcomes than people who control their blood glucose levels in a
standard way. The purpose of this study is to evaluate the effectiveness of using a
traditional method of controlling blood glucose levels versus a tailored, more intensive
method of glucose control on neurological outcomes in people with diabetes who are
undergoing heart surgery. Researchers will also examine genetic factors that may be
associated with insulin resistance and inflammation.
This study will enroll people undergoing heart surgery. On the day before surgery,
participants will undergo a blood collection and neuropsychological testing. They will then
be randomly assigned to either a traditional method of blood glucose control or an
intensive, tailored method of blood glucose control. Participants following the traditional
method of blood glucose control may receive insulin several times a day, based on the
results of glucose monitoring. Participants following the intensive, tailored method of
blood glucose control will undergo hourly measurements of their glucose levels and receive
insulin adjustments as needed to maintain a glucose level of 100-140 mg/dL. During surgery,
all participants will undergo an ultrasound of their neck to monitor blood vessel activity.
Additional blood samples will be collected during surgery, 6 hours after surgery, 24 hours
after surgery, and upon hospital discharge or 5 days after surgery.
One week after surgery or just before leaving the hospital, participants will undergo a
magnetic resonance imaging (MRI) procedure and neuropsychological testing. Before leaving
the hospital, participants will take part in a diabetes education session and nutrition
counseling. Three to 6 weeks and 6 months after surgery, participants will undergo repeat
neuropsychological testing. Once a month for 6 months, participants who received the
intensive, tailored method of blood glucose control will attend study visits at which time
study researchers will monitor their diabetes.
and developing cognitive functioning problems than people without diabetes who undergo heart
surgery. There may be a connection between disturbances in glucose metabolism, endothelial
dysfunction, and poor neurological outcomes after heart surgery. People with diabetes who
receive more intensive blood glucose management during and after heart surgery may have
better neurological outcomes than people who control their blood glucose levels in a
standard way. The purpose of this study is to evaluate the effectiveness of using a
traditional method of controlling blood glucose levels versus a tailored, more intensive
method of glucose control on neurological outcomes in people with diabetes who are
undergoing heart surgery. Researchers will also examine genetic factors that may be
associated with insulin resistance and inflammation.
This study will enroll people undergoing heart surgery. On the day before surgery,
participants will undergo a blood collection and neuropsychological testing. They will then
be randomly assigned to either a traditional method of blood glucose control or an
intensive, tailored method of blood glucose control. Participants following the traditional
method of blood glucose control may receive insulin several times a day, based on the
results of glucose monitoring. Participants following the intensive, tailored method of
blood glucose control will undergo hourly measurements of their glucose levels and receive
insulin adjustments as needed to maintain a glucose level of 100-140 mg/dL. During surgery,
all participants will undergo an ultrasound of their neck to monitor blood vessel activity.
Additional blood samples will be collected during surgery, 6 hours after surgery, 24 hours
after surgery, and upon hospital discharge or 5 days after surgery.
One week after surgery or just before leaving the hospital, participants will undergo a
magnetic resonance imaging (MRI) procedure and neuropsychological testing. Before leaving
the hospital, participants will take part in a diabetes education session and nutrition
counseling. Three to 6 weeks and 6 months after surgery, participants will undergo repeat
neuropsychological testing. Once a month for 6 months, participants who received the
intensive, tailored method of blood glucose control will attend study visits at which time
study researchers will monitor their diabetes.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
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