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OpenTrials
Completed

NCT Number: NCT00576394

Aggressive Versus Moderate Glycemic Control in Diabetic Coronary Bypass Patients

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.

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Key information

Conditions

Glycemic Control Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All diabetic patients undergoing Coronary Bypass Surgery

Exclusion criteria

  • Patients with hepatic and renal failure

Treatment and study plan

IV Insulin drip

Drug

IV insulin drip at 100units insulin in 100ml saline designed to keep blood glucose between 120-180mg/dl

Insulin

Drug

IV insulin drip to keep serum glucose between 80-120mg/dl.

Primary outcomes

  1. Incidence of Hypoglycemia

    Time frame: 24 hours following surgery

Secondary outcomes

  1. free fatty acid levels

    Time frame: 24 hours following surgery

Sponsors and collaborators

Lead sponsor

American Heart Association

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Impact of Aggressive Versus Moderate Glycemic Control on Clinical Outcomes Following Coronary Artery Bypass Graft Surgery in Diabetic Patients

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2007
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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