The primary objective of this study is to answer whether improving preoperative glycaemic control in patients with poorly controlled diabetes mellitus can lower fasting glucose levels on the day of surgery.Secondary objectives are to determine…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the study will be the preoperative fasting glucose
concentration.
Secondary outcome
Secondary outcomes are postoperative blood glucose concentrations, incidence of
hyperglycaemia and hypoglycaemia (glucose >10 mmol l-1 or <4 mmol l-1,
respectively) and change from baseline HbA1c, fructosamine, and
1,5-anhydroglucitol. Finally, number of days at home up to 30 days after
surgery will be assessed, which is a single, pragmatic, patient-centred
outcome.
Background summary
Poor glycaemic control, indicated by an elevated HbA1c, is correlated to poor
postoperative outcome in patients with diabetes mellitus undergoing surgery.
However, improving glycaemic control before surgery has not been extensively
studied so far. Reducing perioperative blood glucose has been associated with a
decrease in postoperative complications. We hypothesise that improving
glycaemic control using an individualised approach guided by a specialised
diabetes care nurse, will significantly lower preoperative fasting glucose,
which is associated with improved perioperative glucose control and less
postoperative complications.
Study objective
The primary objective of this study is to answer whether improving preoperative
glycaemic control in patients with poorly controlled diabetes mellitus can
lower fasting glucose levels on the day of surgery.
Secondary objectives are to determine whether preoperative consultation with a
specialised diabetes care nurse is effective in improving average glycaemic
control as well as postoperative outcomes.
Study design
Pragmatic, non-blinded, randomised, clinical intervention study.
Intervention
On the day of preoperative consultation, HbA1c will be measured. Patients with
an HbA1c <53 mmol/mol will proceed to surgery according to standard care.
Patients with an HbA1c >=53 mmol/mol and < 100 mmol/mol will be randomised to
an intervention group or control group. Patients in the intervention group will
be contacted by a diabetes care nurse for optimisation of their glycaemic
control before surgery. Patients in the control group will proceed to surgery
according to standard care.
Study burden and risks
For study purposes 12 ml of blood will be drawn at two timepoints. At the
outpatient clinic, an extra bloodsample will be drawn during the preoperative
venipuncture which is part of standard care. On the day of the operation, blood
will be drawn using the i.v. the patient already received before the operation.
Therefore, no extra venipunctures will be performed for study purposes.
Patients in the intervention group will be contacted by the diabetes care nurse
for optimisation of their glycaemic control. All patients will be contacted at
30 days after surgery.
Risks associated with the present study are deemed minimal since no
investigational products will be used and treatment adjustments are done by a
nurse specialised in guiding patients with diabetes mellitus and who is
supervised by a consultant endocrinologist. Possible benefits for patients are
a possible reduction in postoperative complications as well as a long term
improvement in glycaemic control, also after surgery.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Diabetes mellitus type 2 (diagnosis at least 3 months prior to pre-operative screening)
- Age 18 - 85 years
- Elective non-cardiac surgery
- Scheduled for surgery at least 7 days from date of screening
- Informed consent
Exclusion criteria
- Bariatric surgery
- Palliative surgery
- Outpatient or day case surgery
- (Potentially) pregnant or breast-feeding
- Unable to communicate in Dutch or English, psychiatric disorder, known therapy incompliance or deemed unfit by the researchers for another reason
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL67034.018.18 |