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

Diabetes Mellitus Type II Clinical Trial

— PILGRIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036372
• Other study ID #: NL 41467.018.12
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2017

Study information

• Verified date: July 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Signed informed consent

• known diabetes mellitus type II for > 3 months

• aged 18-75 years

• scheduled for elective non-cardiac surgery

Exclusion Criteria:

• Daily insulin dosage of > 1 IU/kg body weight

• Oral corticosteroid use

• Planned for day-care (ambulant) surgery

• Planned ICU stay post-operatively

• Planned bowel surgery

• History of chronic pancreatitis or idiopathic acute pancreatitis

• Impaired renal function defined as serum-creatinine = 133 µmol/L for males and = 115 µmol/L for females

• Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)

• Known or suspected allergy to trial product(s) or related products

• Any condition that the local investigator feels would interfere with trial participation or the evaluation of results

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Liraglutide

• Insulin bolus

• GIK infusion
continuous infusion

Locations

Country	Name	City	State
Netherlands	Academic Medical Center Amsterdam	Amsterdam	Please Select
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Netherlands	Diakonessenhuis	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median glucose	The difference in median glucose between the GIK + BR and LG group 1 hour after surgery	1 hour after surgery
Secondary	Total Insulin administration	The difference in insulin administration between the GIK + BR and LG group within 24 h after start of surgery	1 day postoperative
Secondary	Median glucose	The difference in median glucose between the GIK + BR and LG group 4 hours and 1 day after surgery	4 hours and 1 day postoperative
Secondary	Postoperative complications	The difference in proportion of any postoperative complication within the first month	1 month after surgery
Secondary	Hypoglycemia	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	From start treatment until the morning of day 1 postoperative
Secondary	Hypo- and hyperkalemia	The occurrence of hypokalemia (<3.5 mmol/l) and hyperkalemia (>5.0 mmol/l) during and up to 24 h after surgery	from start treatment until morning of day 1 postoperative
Secondary	Glucose	the difference in median glucose 1hr preoperative, 1, 4 hours postoperative, 1 day postoperative between the three groups.	From start treatment until morning of day 1 postoperative

External Links

•   American Diabetes Association