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

Phase 4

Completed

Conditions: diabetes mellitus
10018424
10017998

Registration Number: NL-OMON43712

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 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

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in median glucose between the GIK + BR and LG group 1 hour after<br /><br>surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* The difference in insulin administration during the trail between the GIK, BR<br /><br>and LG group<br /><br>* The difference in median glucose between the GIK, BR and LG group 1 hour, 4<br /><br>hours and 1 day after surgery<br /><br>* The difference in proportion of any postoperative complication within the<br /><br>first month.<br /><br>* The occurrence of mild and severe hypoglycaemia (glucose <4.0 mmol/l and <2.3<br /><br>mmol/l, respectively)<br /><br>* The occurrence of hypokalemia (<3.5 mmol/l) and hyperkalemia (>5.0 mmol/l)</p><br>