- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02036372
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
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Amsterdam, Netherlands
- Onze Lieve Vrouwe Gasthuis
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Utrecht, Netherlands, 3582 KE
- Diakonessenhuis
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Please Select
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Amsterdam, Please Select, Netherlands, 1105AZ
- Academic Medical Center Amsterdam
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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)
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Other Names:
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Experimental: LG (Liraglutide)
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Other Names:
Other Names:
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Active Comparator: GIK (glucose -insulin - potassium) infusion
I= (PG-7)/(200/W)+8 I=Insulin amount, PG=glucose 30 minutes preoperative, W= body weight in kg
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continuous infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Median glucose
Time Frame: 1 hour after surgery
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The difference in median glucose between the GIK + BR and LG group 1 hour after surgery
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1 hour after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Insulin administration
Time Frame: 1 day postoperative
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The difference in insulin administration between the GIK + BR and LG group within 24 h after start of surgery
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1 day postoperative
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Median glucose
Time Frame: 4 hours and 1 day postoperative
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The difference in median glucose between the GIK + BR and LG group 4 hours and 1 day after surgery
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4 hours and 1 day postoperative
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Postoperative complications
Time Frame: 1 month after surgery
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The difference in proportion of any postoperative complication within the first month
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1 month after surgery
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Hypoglycemia
Time Frame: From start treatment until the morning of day 1 postoperative
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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
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From start treatment until the morning of day 1 postoperative
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Hypo- and hyperkalemia
Time Frame: from start treatment until morning of day 1 postoperative
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The occurrence of hypokalemia (<3.5 mmol/l) and hyperkalemia (>5.0 mmol/l) during and up to 24 h after surgery
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from start treatment until morning of day 1 postoperative
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Glucose
Time Frame: From start treatment until morning of day 1 postoperative
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the difference in median glucose 1hr preoperative, 1, 4 hours postoperative, 1 day postoperative between the three groups.
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From start treatment until morning of day 1 postoperative
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Collaborators and Investigators
Investigators
- Principal Investigator: Benedikt Preckel, MD, PhD, Academic Medical Centre - AMC-UvA
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL 41467.018.12
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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