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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00836329
First received: February 2, 2009
Last updated: September 30, 2014
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus
Cardiovascular Diseases
Behavioral: Intensive Glucose Management
Behavioral: Traditional Glucose Management:
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Neurologic Outcomes in Diabetics Undergoing Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Proportion of participants with identifiable brain lesions detected by magnetic resonance imaging (MRI) [ Time Frame: Measured 1 week after surgery ] [ Designated as safety issue: No ]
  • Proportion of participants with new neuropsychological deficits (20% decline on two or more neuropsychological tests) [ Time Frame: Measured 6 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of lesions, as measured by MRI [ Time Frame: Measured 1 week after surgery ] [ Designated as safety issue: No ]
  • Size of lesions, as measured by MRI [ Time Frame: Measured 1 week after surgery ] [ Designated as safety issue: No ]
  • Genetic analysis (i.e., predictive utility of haplotype assignment on primary outcomes) [ Time Frame: Measured 6 months after surgery ] [ Designated as safety issue: No ]
  • Neuropsychological deficits (i.e., predictive utility of neuropsychological performance on presence, number, and volume of lesions) [ Time Frame: Measured 6 months after surgery ] [ Designated as safety issue: No ]

Enrollment: 133
Study Start Date: December 2008
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive Glucose Management
Participants will receive intensive glucose management.
Behavioral: 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.
Active Comparator: Traditional Glucose Management
Participants will receive a traditional method of glucose management.
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00836329

Locations
United States, North Carolina
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States, 27057
Sponsors and Collaborators
Investigators
Principal Investigator: Edward H. Kincaid, MD Wake Forest Baptist Health
Study Director: Jorge Calles-Escandon, MD Wake Forest Baptist Health
Study Director: Donald W. Bowden, PhD Wake Forest Baptist Health
Study Director: David A. Stump, PhD Wake Forest Baptist Health
  More Information

No publications provided

Responsible Party: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00836329     History of Changes
Other Study ID Numbers: 615, R01 HL089115-01
Study First Received: February 2, 2009
Last Updated: September 30, 2014
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Neurologic
Diabetes
Cardiac Surgery
Stroke

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014