We hypothesize that liraglutide treatment (a GLP-1 analogue), initiated before cardiac surgery, is effective in lowering the number of patients needing perioperative insulin adjustments and reducing the total amount of insulin needed in the…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is reduction in the number of patients needing
perioperative insulin treatment when aiming for plasma glucose < 8 mmol l-1.
Secondary outcome
We will assess the following secondary outcome parameters:
* Total perioperative insulin use (IU/day)
* Number of insulin administrations
* Composite postoperative complications*
* Glucose control in the perioperative period, as assessed by the mean
perioperative glucose
* Number of perioperative hyperglycaemic events (>11 mmol l-1)
* Number of moderate perioperative hypoglycaemic events (<4 mmol l-1)
* Number of severe perioperative hypoglycaemic events (<2.3 mmol l-1)
* Percentage of time spent in target range (%TIR) for CGM measurements
* Proportion of patients with postoperative nausea and vomiting
Background summary
Hyperglycemie ontwikkelt zich in de meerderheid van patiënten die cardiale
chirurgie ondergaan. Er is een duidelijke associatie tussen hyperglycemie en
postoperatieve complicaties. De implementatie van perioperatieve insuline
behandeling wordt gehinderd door het risico op hypoglycemie. Glucagon Like
Peptide 1 (GLP-1) behandeling is een veelbelovende therapie voor perioperatieve
hyperglycemie tijdens cardiale chirurgie. Het heeft het potentieel om glucose
te verlagen en de nood aan insuline te verminderen. Zodoende kan het, het
risico op iatrogene hypoglycemie verkleinen.
Study objective
We hypothesize that liraglutide treatment (a GLP-1 analogue), initiated before
cardiac surgery, is effective in lowering the number of patients needing
perioperative insulin adjustments and reducing the total amount of insulin
needed in the perioperative period when aiming for a moderate glucose target of
< 8 mmol l-1.
Study design
We will perform a randomized double blind placebo controlled trial in 5 Dutch
cardiac surgery centres.
Intervention
Patients will be randomized (1:1) to perioperative liraglutide treatment or
placebo. Liraglutide or placebo 0.6 mg subcutaneously (sc) the day before
surgery and 1.2 mg sc on the day of surgery will be administered. In both arms
the glucose target range is <8 mmol l-1.
Study burden and risks
For study purposes, an additional 18.4 ml of blood will be drawn. This will be
taken from intravenous or intra-arterial catheters that have been inserted for
clinical purposes. Common adverse events with liraglutide treatment are related
to the gastrointestinal system, nausea and diarrhoea as reported most
frequently. In addition, there is a small risk of hypoglycaemia, which is
minimized by frequent glucose monitoring. All adverse events are mostly mild
and the drop-out rate from clinical trials due to adverse events has been low.
Patient might benefit from this intervention by improved perioperative glucose
control without insulin. This reduces hypoglycaemia risk and might reduce other
postoperative complications. In general this study will provide more insight in
the effect of liraglutide as a glucose-lowering agent to prevent insulin use in
the perioperative setting.
Before the first study drug treatment the sensor of a subcutaneous continuous
glucose monitor is inserted into the subcutaneous tissue. This will be done in
a subset of 26 patients (see sample size calculation) included in the AMC or
OLVG (for logistical reasons).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Adult patients, aged 18-80 years (inclusive),
* No known diabetes mellitus, or
* Known diabetes mellitus type 2 on oral glucose lowering medication, diet or total daily insulin dose *0.5 IU/kg
* Scheduled for an elective cardiac surgical procedure.
* Informed consent obtained before any trial-related activities are carried out.
Exclusion criteria
* Diabetes mellitus type 1
* Emergency surgery
* Receiving oral corticosteroid therapy
* History of pancreatic surgery or acute or chronic pancreatitis
* Personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2)
* Heart failure NYHA class IV
* Serum-creatinine * 133 *mol l-1 for males and * 115 *mol l-1 for females
* Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
* Current treatment with GLP-1 analogues
* Known or suspected allergy to trial products or other drugs in the same class
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2017-000043-40-NL |
| CCMO | NL60461.018.17 |
| Other | Reeds ingediend bij NTR, registratie nog niet afgerond. |