NCT02036372

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

January 10, 2014

Last Update Submit

July 19, 2023

Conditions

Diabetes Mellitus Type II

Keywords

glucosediabetes mellitusperioperative

Outcome Measures

Primary Outcomes (1)

  • Median glucose

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

    1 hour after surgery

Secondary Outcomes (6)

  • Total Insulin administration

    1 day postoperative

  • Median glucose

    4 hours and 1 day postoperative

  • Postoperative complications

    1 month after surgery

  • Hypoglycemia

    From start treatment until the morning of day 1 postoperative

  • Hypo- and hyperkalemia

    from start treatment until morning of day 1 postoperative

  • +1 more secondary outcomes

Study Arms (3)

BR (bolus regimen)

EXPERIMENTAL

* Day before surgery: half evening dose long acting insulin * Day of surgery: * patients using mealtime and longacting insulin/NPH: withhold mealtime morning dose, stop glucose lowering tablets * patients using only long acting insulin/NPH: half dose of long-acting or NPH insulin, stop glucose lowering tablets * Measure blood glucose every 60 minutes, start 30 min prior to surgery * Give bolus of insulin according to treatment algorithm

Drug: Insulin bolus

LG (Liraglutide)

EXPERIMENTAL

* Day before surgery: half dose of long acting and mealtime insulin from start liraglutide * Day of surgery: withhold own insulin, stop oral glucose lowering tablets * Start with 0.6 mg liraglutide subcutaneously (s.c.) the day prior to surgery at 17.00hr. * In case of nausea graded higher than minimal, the patient will be excluded from the study * Otherwise, treatment will be continued with 1.2 mg liraglutide s.c. per day on the day of surgery at 07.00hr. * Measure glucose every 60 minutes, start 30 min prior to surgery * Adjust according to bolus algorithm of BR group

Drug: LiraglutideDrug: Insulin bolus

GIK (glucose -insulin - potassium) infusion

ACTIVE COMPARATOR

* Day before surgery: half evening dose long acting insulin * Day of surgery: stop oral glucose lowering tablets and withhold own insulin. * GIK infusion: 500 cc glucose 5% with insulin and 10 mmol KCL per 500 cc. Start at 83 ml/hr. * Calculate the insulin amount in the GIK infusion according to the formula: I= (PG-7)/(200/W)+8 I=Insulin amount, PG=glucose 30 minutes preoperative, W= body weight in kg * Measure blood glucose every 60 minutes, start 30 min prior to surgery * Adjust glucose \> 8 mmol/l according to treatment algorithm

Drug: GIK infusion

Interventions

LiraglutideDRUG
Also known as: Victoza
LG (Liraglutide)
Insulin bolusDRUG
Also known as: novorapid
BR (bolus regimen)LG (Liraglutide)
GIK infusionDRUG

continuous infusion

Also known as: glucose, insulin, potassium infusion
GIK (glucose -insulin - potassium) infusion

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • known diabetes mellitus type II for \> 3 months
  • aged 18-75 years
  • scheduled for elective non-cardiac surgery

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Academic Medical Center Amsterdam

Amsterdam, Please Select, 1105AZ, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Diakonessenhuis

Utrecht, 3582 KE, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 25419179DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

LiraglutideInsulin AspartGlucoseInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsInsulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesPeptidesAmino Acids, Peptides, and ProteinsHexosesMonosaccharidesSugarsCarbohydratesProinsulin

Study Officials

  • Benedikt Preckel, MD, PhD

    Academic Medical Centre - AMC-UvA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof dr B Preckel, MD, PhD

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 15, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations

NL(3)