NCT02036372

Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus

PILGRIM - Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus Type II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The incidence of diabetes mellitus type II is increasing. More and more patients who need surgery have diabetes mellitus type II. Despite an enormous amount of glucose lowering protocols and the proven negative effects of hyperglycaemia. There is no evidence for the optimal glucose lowering protocol. This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1 (liraglutide, LG) treatment.

Detailed description

Diabetes mellitus is associated with poor outcome after surgery. The prevalence of diabetes in hospitalised patients is up to 40%, meaning that the anaesthesiologist will encounter a diabetes patient in the operating room on a daily basis. Multiple protocols for perioperative glucose regulation have been developed, ranging from intravenous glucose-insulin-potassium infusion to subcutaneous bolus regimens. Despite this abundance of published glucose lowering protocols and the proven negative effects of intraoperative hyperglycaemia in diabetes, there is no evidence regarding the optimal intraoperative glucose lowering treatment. Recently, incretins have been introduced to lower blood glucose. The main hormone of the incretin system is glucagon-like peptide-1 (GLP-1). GLP-1 increases insulin and decreases glucagon secretion in a glucose-dependent manner, resulting in low incidence of hypoglycaemia. This study investigates for the first time the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus undergoing non-cardiac surgery. Objective: This study investigates the optimal intraoperative treatment algorithm to lower glucose in patients with diabetes mellitus type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GLP-1 (liraglutide, LG) treatment.

Conditions

• Diabetes Mellitus Type II

Interventions

Type	Name	Description
DRUG	Liraglutide
DRUG	Insulin bolus
DRUG	GIK infusion	continuous infusion

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2014-01-15
• Last updated: 2023-07-20

Locations

3 sites across 1 country: Netherlands