liraglutide
DrugOther names: Victoza
NCT Number: NCT02036372
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.
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Academic Medical Center Amsterdam, Amsterdam, Please Select, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Victoza
Other names: novorapid
continuous infusion
Other names: glucose, insulin, potassium infusion
Time frame: 1 hour after surgery
The difference in median glucose between the GIK + BR and LG group 1 hour after surgery
Time frame: 1 day postoperative
The difference in insulin administration between the GIK + BR and LG group within 24 h after start of surgery
Time frame: 4 hours and 1 day postoperative
The difference in median glucose between the GIK + BR and LG group 4 hours and 1 day after surgery
Time frame: 1 month after surgery
The difference in proportion of any postoperative complication within the first month
Time frame: From start treatment until the morning of day 1 postoperative
The occurrence of mild and severe hypoglycemia (glucose <4.0 mmol/l and <2.3 mmol/l, respectively) during and up to 24 h after surgery
Time frame: from start treatment until morning of day 1 postoperative
The occurrence of hypokalemia (<3.5 mmol/l) and hyperkalemia (>5.0 mmol/l) during and up to 24 h after surgery
Time frame: From start treatment until morning of day 1 postoperative
the difference in median glucose 1hr preoperative, 1, 4 hours postoperative, 1 day postoperative between the three groups.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
PILGRIM - Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus Type II
Acronym: PILGRIM
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.
Published trials that share one or more normalized conditions with this study.
NCT02144948
Diabetes Mellitus, Diabetes Mellitus Type II
Dresden, Germany
View Trial DetailsNCT01669473
Autoimmune Diseases, Diabetes Mellitus
Chicago, Illinois, United States
View Trial DetailsNCT01684813
Acute Coronary Syndrome, Cardiovascular Diseases
Seville, Spain
View Trial DetailsNCT01252524
Diabetes Mellitus, Diabetes Mellitus Type II
Greenville, North Carolina, United States
View Trial Details