to study the feasibility of lowering HbA1c before elective surgery in patients with suboptimalpoorly controlled DM (HbA1c >7%/53 mmol/mol).
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
the main outcome parameter is the proportion of patients in which HbA1c
lowering is successful (ie > 10 mmol/mol decrease inclusion-surgery or HbA1c
before surgery <53 mmol/mol), comparing HbA1c at inclusion with HbA1c on the
day of surgery.
Secondary outcome
As secondary outcome we will ask the patient to perform a fasting plasma
glucose fingerstick measurement in the week of study inclusion and on the day
of surgery. Also, complications will be registered for evaluation, although
this study will to assess any relation between HbA1c and complications.
Background summary
Preoperative HbA1c values are related to the risk of postoperative
complications and mortality in patients with diabetes mellitus (DM). Therefore,
the effect of preoperative HbA1c lowering on postoperative complications in
poorly regulated diabetes mellitus (DM) patients should be studiedevaluated.
However, until now it is unknown whether it is possible at all to lower HbA1c
in patients awaiting elective surgery within a relatively short time period.
Study objective
to study the feasibility of lowering HbA1c before elective surgery in patients
with suboptimalpoorly controlled DM (HbA1c >7%/53 mmol/mol).
Study design
We will perform a single-centre open label pilot trial.
Intervention
All participating subjects will be referred to the in-hospital diabetes nurse
(IHDN) for optimisation of their DM treatment.
Study burden and risks
Risk associated with this study are is comparable to routinely lowering HbA1c
in the outpatient setting. The main risk is therefore hypoglycaemia, and this
will be prevented as much as possible in clinical practice . Possible benefit
is improvement of diabetes regulation and reduction in postoperative
complications. In general, this study will be the first step towards a
randomized controlled trial, studying the possible benefits of lowering
postoperative complications in patients with DM.
Meibergdreef 9
Amsterdam 1100DD
NL
Meibergdreef 9
Amsterdam 1100DD
NL
Listed location countries
Age
Inclusion criteria
- Diagnosis of DM type 2 at least 3 months prior to the screening
- Adult patients, age 18-80 years inclusive
- HbA1c >7% (53 mmol/mol) as measured at the pre-assessment clinic
- Scheduled for elective surgery
- Willing and able to provide written informed consent
Exclusion criteria
- Emergency surgery or scheduled surgery < 3 weeks
- Palliative oncological surgery
- Underlying condition that does not allow patients to participate in the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL61715.018.17 |
| Other | volgt |
| OMON | NL-OMON29027 |