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

NL 41467.018.12

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.

2014-01-01

2017-01-01

2017-01-01

Completed

150

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}

2023-07-20