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Diabetes Mellitus Type IIPILGRIMNCT02036372

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

A study testing Liraglutide, Insulin bolus and GIK infusion in people with Diabetes Mellitus Type II, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus Type II
What is being tested?
Liraglutide, Insulin bolus and GIK infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
3 sitesNetherlands
Study dates
Jan 2014to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

  • Academic Medical Center Amsterdam

    Amsterdam, Please Select, 1105AZ

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam

  • Diakonessenhuis

    Utrecht, 3582 KE

Other trials in Netherlands

About this study

Official title: 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.

Read the 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.

Being tested
Liraglutide, Insulin bolus, GIK infusion
Keywords
glucose, diabetes mellitus, perioperative
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

    Also called Victoza

  • Insulin bolusDrug

    Also called novorapid

  • GIK infusionDrug

    Also called glucose, insulin, potassium infusion

    continuous infusion

Study groups in NCT02036372
Study groupRoleWhat they receive
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
Receives: 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
Receives: Drug: Liraglutide; Drug: Insulin bolus
GIK (glucose -insulin - potassium) infusionActive 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
Receives: Drug: GIK infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median glucose

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

    Measured: 1 hour after surgery

Secondary outcomes (6)

  1. Total Insulin administration

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

    Measured: 1 day postoperative

  2. Median glucose

    The difference in median glucose between the GIK + BR and LG group 4 hours and 1 day after surgery

    Measured: 4 hours and 1 day postoperative

  3. Postoperative complications

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

    Measured: 1 month after surgery

  4. 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

    Measured: From start treatment until the morning of day 1 postoperative

  5. 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

    Measured: from start treatment until morning of day 1 postoperative

  6. Glucose

    the difference in median glucose 1hr preoperative, 1, 4 hours postoperative, 1 day postoperative between the three groups.

    Measured: From start treatment until morning of day 1 postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02036372
Sponsor's protocol ID
NL 41467.018.12
Acronym
PILGRIM
Status last verified
Jul 2023
First submitted
10 Jan 2014
Last updated
20 Jul 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25419179

Questions about this trial

What is this clinical trial studying?

A study testing Liraglutide, Insulin bolus and GIK infusion in people with Diabetes Mellitus Type II, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median glucose (time frame: 1 hour after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02036372, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.

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