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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR (bolus regimen) | Experimental |
|
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| LG (Liraglutide) | Experimental |
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| GIK (glucose -insulin - potassium) infusion | Active Comparator |
I= (PG-7)/(200/W)+8 I=Insulin amount, PG=glucose 30 minutes preoperative, W= body weight in kg
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug |
|
| |
| Insulin bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Median glucose | The difference in median glucose between the GIK + BR and LG group 1 hour after surgery | 1 hour after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Insulin administration | The difference in insulin administration between the GIK + BR and LG group within 24 h after start of surgery | 1 day postoperative |
| Median glucose | The difference in median glucose between the GIK + BR and LG group 4 hours and 1 day after surgery |
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Inclusion Criteria:
Exclusion Criteria:
- Daily insulin dosage of > 1 IU/kg body weight
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| Name | Affiliation | Role |
|---|---|---|
| Benedikt Preckel, MD, PhD | Academic Medical Centre - AMC-UvA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center Amsterdam | Amsterdam | Please Select | 1105AZ | Netherlands | ||
| Onze Lieve Vrouwe Gasthuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25419179 | Derived | 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. |
| Label | URL |
|---|---|
| American Diabetes Association | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D061267 | Insulin Aspart |
| D005947 | Glucose |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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| Drug |
|
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| GIK infusion | Drug | continuous infusion |
|
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| 4 hours and 1 day postoperative |
| Postoperative complications | The difference in proportion of any postoperative complication within the first month | 1 month after surgery |
| 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 | From start treatment until the morning of day 1 postoperative |
| 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 | from start treatment until morning of day 1 postoperative |
| Glucose | 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 |
| Amsterdam |
| Netherlands |
| Diakonessenhuis | Utrecht | 3582 KE | Netherlands |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D011384 | Proinsulin |