Clinical trial NCT02036372: Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus
Official title: PILGRIM - Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus Type II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type II
Keywords: glucose
diabetes mellitus
perioperative
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2014-01-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Median glucose
timeFrame: 1 hour after surgery
Secondary outcomes:
measure: Total Insulin administration
timeFrame: 1 day postoperative
measure: Median glucose
timeFrame: 4 hours and 1 day postoperative
measure: Postoperative complications
timeFrame: 1 month after surgery
measure: Hypoglycemia
timeFrame: From start treatment until the morning of day 1 postoperative
measure: Hypo- and hyperkalemia
timeFrame: from start treatment until morning of day 1 postoperative
measure: Glucose
timeFrame: From start treatment until morning of day 1 postoperative
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
state: Please Select
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Utrecht
country: Netherlands
facility: Diakonessenhuis
Study officials:
affiliation: Academic Medical Centre - AMC-UvA
name: Benedikt Preckel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polderman JA, Houweling PL, Hollmann MW, DeVries JH, Preckel B, Hermanides J. Study protocol of a randomised controlled trial comparing perioperative intravenous insulin, GIK or GLP-1 treatment in diabetes-PILGRIM trial. BMC Anesthesiol. 2014 Oct 14;14:91. doi: 10.1186/1471-2253-14-91. eCollection 2014.