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

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis
      • Utrecht, Netherlands, 3582 KE
        • Diakonessenhuis
    • Please Select
      • Amsterdam, Please Select, Netherlands, 1105AZ
        • Academic Medical Center Amsterdam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BR (bolus regimen)
  • 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
Other Names:
  • novorapid
Experimental: LG (Liraglutide)
  • 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
Other Names:
  • Victoza
Other Names:
  • novorapid
Active Comparator: GIK (glucose -insulin - potassium) infusion
  • 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
continuous infusion
Other Names:
  • glucose, insulin, potassium infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median glucose
Time Frame: 1 hour after surgery
The difference in median glucose between the GIK + BR and LG group 1 hour after surgery
1 hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day postoperative
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
4 hours and 1 day postoperative
Postoperative complications
Time Frame: 1 month after surgery
The difference in proportion of any postoperative complication within the first month
1 month after surgery
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
From start treatment until the morning of day 1 postoperative
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
from start treatment until morning of day 1 postoperative
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.
From start treatment until morning of day 1 postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benedikt Preckel, MD, PhD, Academic Medical Centre - AMC-UvA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 13, 2014

First Posted (Estimated)

January 15, 2014

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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