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

NCT00836329 | Completed Phase 3 DMC

• 2 other identifiers: 615R01HL089115-01
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Cardiovascular Diseases

Keywords

Neurologic; Diabetes; Cardiac Surgery; Stroke

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with identifiable brain lesions detected by magnetic resonance imaging (MRI)

  Measured 1 week after surgery

• Proportion of participants with new neuropsychological deficits (20% decline on two or more neuropsychological tests)

  Measured 6 months after surgery

Secondary Outcomes (4)

• Number of lesions, as measured by MRI

  Measured 1 week after surgery

• Size of lesions, as measured by MRI

  Measured 1 week after surgery

• Genetic analysis (i.e., predictive utility of haplotype assignment on primary outcomes)

  Measured 6 months after surgery

• Neuropsychological deficits (i.e., predictive utility of neuropsychological performance on presence, number, and volume of lesions)

  Measured 6 months after surgery

Study Arms (2)

Intensive Glucose Management

EXPERIMENTAL

Participants will receive intensive glucose management.

Behavioral: Intensive Glucose Management

Traditional Glucose Management

ACTIVE COMPARATOR

Participants will receive a traditional method of glucose management.

Behavioral: Traditional Glucose Management:

Interventions

Intensive Glucose Management 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.

Intensive Glucose Management

Traditional Glucose Management: 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.

Traditional Glucose Management

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Cardiovascular Diseases; Neurologic Manifestations; Stroke

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases

Study Officials

• Edward H. Kincaid, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

• Jorge Calles-Escandon, MD

  Wake Forest University Health Sciences

  STUDY DIRECTOR

• Donald W. Bowden, PhD

  Wake Forest University Health Sciences

  STUDY DIRECTOR

• David A. Stump, PhD

  Wake Forest University Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: July 12, 2016

Record last verified: 2009-07

Locations

US (1)