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

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study ID
NCT02036372
Status
Completed

Conditions

  • Diabetes Mellitus Type II

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide — DRUG
  • Insulin bolus — DRUG
  • GIK infusion — DRUG
    continuous infusion

Study Details

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.

Key Dates

Start date
Jan 31, 2014
Status verified
Jul 2023
Primary completion
Jan 31, 2017
Completion
Jan 31, 2017

Study Design

Enrollment
150 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BR (bolus regimen)
    * 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
  • Experimental: LG (Liraglutide)
    * 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
  • Active Comparator: GIK (glucose -insulin - potassium) infusion
    * 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

Primary Outcome Measure

Median glucose [ Time Frame: 1 hour after surgery ]

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