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Continuation of Metformin during surgery in patients with diabetes mellitus type 2

Continuation of Metformin during surgery in patients with diabetes mellitus type 2 - MD trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41974
Enrollment
70
Registered
2015-06-12
Start date
2015-07-07
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Diabetes

Interventions

Stopping metformin use 24 hours preoperatively.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The difference in postoperative glucose values 2 hours after surgery

Secondary

MeasureTime frame
The difference in fasting glucose values at day 1 after surgery. The difference in lactate levels 2 hours after surgery and at day 1 after surgery. The difference in the amount of insulin administered during surgery. The occurrence of mild and severe hypoglycaemia (glucose

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)