Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery

NCT ID: NCT00836329

Last Updated: 2016-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2014-05-31

Brief Summary

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.

Detailed Description

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.

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive Glucose Management

Participants will receive intensive glucose management.

Group Type: EXPERIMENTAL

Intensive Glucose Management

Intervention Type: BEHAVIORAL

Participants in the intensive glucose management group will undergo strict management of their blood glucose levels with a target whole blood glucose level of 100-140 mg/dL preoperatively, intraoperatively, and postoperatively in the intensive care unit (ICU). Once meals are started, targets for glycemia management will be (a) fasting: 80-140 mg/dL, (b) postprandial: 140-180 mg/dL. Prior to hospital discharge, participants will receive an in-depth diabetes education session. After hospital discharge, participants will attend monthly study visits for 6 months so that study researchers can monitor their glycemia management.

Traditional Glucose Management

Participants will receive a traditional method of glucose management.

Group Type: ACTIVE_COMPARATOR

Traditional Glucose Management:

Intervention Type: BEHAVIORAL

Participants will receive traditional management of blood glucose levels while in the hospital. They may receive insulin several times a day, based on the results of glucose monitoring.

Interventions

Intensive Glucose Management

Participants in the intensive glucose management group will undergo strict management of their blood glucose levels with a target whole blood glucose level of 100-140 mg/dL preoperatively, intraoperatively, and postoperatively in the intensive care unit (ICU). Once meals are started, targets for glycemia management will be (a) fasting: 80-140 mg/dL, (b) postprandial: 140-180 mg/dL. Prior to hospital discharge, participants will receive an in-depth diabetes education session. After hospital discharge, participants will attend monthly study visits for 6 months so that study researchers can monitor their glycemia management.

Intervention Type: BEHAVIORAL

Traditional Glucose Management:

Participants will receive traditional management of blood glucose levels while in the hospital. They may receive insulin several times a day, based on the results of glucose monitoring.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward H. Kincaid, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Jorge Calles-Escandon, MD

Role: STUDY_DIRECTOR

Wake Forest University Health Sciences

Donald W. Bowden, PhD

Role: STUDY_DIRECTOR

Wake Forest University Health Sciences

David A. Stump, PhD

Role: STUDY_DIRECTOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

R01HL089115-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

615

Identifier Type: -

Identifier Source: org_study_id