Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576394
Recruitment Status : Completed
First Posted : December 19, 2007
Last Update Posted : June 23, 2015
Eli Lilly and Company
Information provided by (Responsible Party):
Harold L. Lazar MD, American Heart Association

Brief Summary:
entGlycemic control has been found to improve clinical outcomes following Coronary Bypass Surgery. This study tests the hypothesis that obtaining tighter glycemic control(80-120mg/dl) as opposed to more moderate control (120-180mg/dl) will further improve outcomes.

Condition or disease Intervention/treatment Phase
Glycemic Control Drug: IV Insulin drip Drug: Insulin Phase 1

Detailed Description:
150 diabetic patients will be randomized to achieve aggressive glycemic control (80-120mg/dl) vs moderate control (120-180mg/dl) using intravenous insulin infusions beginning at anesthetic induction and continuing for 18 hours following surgery.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients
Study Start Date : October 2006
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1Moderate Glycemic Control
Patients will receive an insulin drip to keep blood glucose levels between 120-180mg/dl
Drug: IV Insulin drip
IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl

Active Comparator: 2Aggressive Glycemic Control
Patients will receive an insulin drip designed to maintain serum glucose between 80-120mg/dl
Drug: Insulin
IV insulin drip to keep serum glucose between 80-120mg/dl.

Primary Outcome Measures :
  1. Incidence of Hypoglycemia [ Time Frame: 24 hours following surgery ]

Secondary Outcome Measures :
  1. free fatty acid levels [ Time Frame: 24 hours following surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All diabetic patients undergoing Coronary Bypass Surgery

Exclusion Criteria:

  • Patients with hepatic and renal failure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576394

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
American Heart Association
Eli Lilly and Company

Publications of Results:
Responsible Party: Harold L. Lazar MD, Professor of Cardiothoracic Surgery, American Heart Association Identifier: NCT00576394     History of Changes
Other Study ID Numbers: H-25760
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015

Keywords provided by Harold L. Lazar MD, American Heart Association:
Glucose, Insulin

Additional relevant MeSH terms:
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs