Diabetes Mellitus Type II
Conditions
Keywords
glucose, diabetes mellitus, perioperative
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.
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.
Interventions
DRUGLiraglutide
DRUGInsulin bolus
DRUGGIK infusion
continuous infusion
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median glucose | 1 hour after surgery | The difference in median glucose between the GIK + BR and LG group 1 hour after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median glucose | 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 |
| Postoperative complications | 1 month after surgery | The difference in proportion of any postoperative complication within the first month |
| Total Insulin administration | 1 day postoperative | The difference in insulin administration between the GIK + BR and LG group within 24 h after start of surgery |
| Hypo- and hyperkalemia | 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 |
| Glucose | 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. |
| Hypoglycemia | 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 |
Countries
Netherlands
Outcome results
None listed