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perioperative intravenous insulin, GIK and GLP-1 treatment in diabetes mellitus

perioperative intravenous insulin, GIK and GLP-1 treatment in diabetes mellitus - PILGRIM

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43712
Enrollment
150
Registered
2013-02-11
Start date
2014-02-17
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetes mellitus

Interventions

Before hospitalisation patients will be informed about the study. Informed consent will be obtained the day before surgery. The participants will be randomized to one of the three treatment groups:

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * Oral corticosteroid use - Insulin dose > 1IE/kg/day * Planned for day-care (ambulant) surgery * Planned ICU stay post-operatively * History of chronic pancreatitis or idiopathic acute pancreatitis * Impaired renal function defined as serum-creatinine * 133 *mol/L for males and * 115 *mol/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 Planned bowel surgery

Design outcomes

Primary

MeasureTime frame
The difference in median glucose between the GIK + BR and LG group 1 hour after surgery

Secondary

MeasureTime frame
* The difference in insulin administration during the trail between the GIK, BR and LG group * The difference in median glucose between the GIK, BR and LG group 1 hour, 4 hours and 1 day after surgery * The difference in proportion of any postoperative complication within the first month. * The occurrence of mild and severe hypoglycaemia (glucose 5.0 mmol/l)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)