GLP-1 for bridging of hyperglycaemia during cardiac surgery: a randomized controlled trial

Phase 4

Completed

Conditions: high blood glucose concentration
10018424

Registration Number: NL-OMON45357

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 274

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is reduction in the number of patients needing<br /><br>perioperative insulin treatment when aiming for plasma glucose < 8 mmol l-1.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will assess the following secondary outcome parameters:<br /><br>* Total perioperative insulin use (IU/day)<br /><br>* Number of insulin administrations<br /><br>* Composite postoperative complications<br /><br> Glucose control in the perioperative period, as assessed by the mean<br /><br>perioperative glucose<br /><br>* Number of perioperative hyperglycaemic events (>11 mmol l-1)<br /><br>* Number of moderate perioperative hypoglycaemic events (<4 mmol l-1)<br /><br>* Number of severe perioperative hypoglycaemic events (<2.3 mmol l-1)<br /><br>* Percentage of time spent in target range (%TIR) for CGM measurements<br /><br>* Proportion of patients with postoperative nausea and vomiting</p><br>