Continuation of Metformin during surgery in patients with diabetes mellitus type 2
- Conditions
- Diabetes10018424
- Registration Number
- NL-OMON41974
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Signed informed consent
Aged 18-80 years
Scheduled for elective non-cardiac surgery
Known diabetes mellitus type 2 for > 3 months
Using metformin > 3 months
Insulin use
Planned day case/outpatient surgery
Planned OR-duration * 45 min
Planned ICU stay post-operatively
Existing severe liver disease or alcohol abuse
Known renal function impairment
Planned corticosteroid treatment perioperatively
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)
Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference in postoperative glucose values 2 hours after surgery</p><br>
- Secondary Outcome Measures
Name Time Method <p>The difference in fasting glucose values at day 1 after surgery.<br /><br>The difference in lactate levels 2 hours after surgery and at day 1 after<br /><br>surgery.<br /><br>The difference in the amount of insulin administered during surgery.<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 difference in length of stay (days) and postoperative complications 30 days<br /><br>after surgery.</p><br>