Skip to main content
OpenTrials
Completed

NCT Number: NCT02036372

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Medical Center Amsterdam, Amsterdam, Please Select, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

liraglutide

Drug

Other names: Victoza

Insulin bolus

Drug

Other names: novorapid

GIK infusion

Drug

continuous infusion

Other names: glucose, insulin, potassium infusion

Primary outcomes

  1. Median glucose

    Time frame: 1 hour after surgery

    The difference in median glucose between the GIK + BR and LG group 1 hour after surgery

Secondary outcomes

  1. Total Insulin administration

    Time frame: 1 day postoperative

    The difference in insulin administration between the GIK + BR and LG group within 24 h after start of surgery

  2. Median glucose

    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

  3. Postoperative complications

    Time frame: 1 month after surgery

    The difference in proportion of any postoperative complication within the first month

  4. Hypoglycemia

    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

  5. Hypo- and hyperkalemia

    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

  6. Glucose

    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.

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Acronym: PILGRIM

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 15, 2014
Registry last updated
Jul 20, 2023

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.