| Trial ID: | L2491 |
| Source ID: | NCT02036372
|
| Associated Drug: |
Liraglutide
|
| Title: |
Perioperative Insulin, GIK or GLP-1 Treatment in Diabetes Mellitus
|
| Acronym: |
PILGRIM
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus Type II
|
| Interventions: |
DRUG: Liraglutide|DRUG: Insulin bolus|DRUG: GIK infusion
|
| Outcome Measures: |
Primary: Median glucose, The difference in median glucose between the GIK + BR and LG group 1 hour after surgery, 1 hour after surgery | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
150
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2014-01
|
| Completion Date: |
2017-01
|
| Results First Posted: |
|
| Last Update Posted: |
2023-07-20
|
| Locations: |
Academic Medical Center Amsterdam, Amsterdam, Please Select, 1105AZ, Netherlands|Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands|Diakonessenhuis, Utrecht, 3582 KE, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT02036372
|
