A randomised, double-blind, double-dummy study of the effects of insulin and glucagon-like peptide-1 on glycaemia, gastric emptying, gastro-oesophageal reflux and mesenteric blood flow in the critically ill

Phase 2

Withdrawn

• Conditions: Glycaemic control; Gastric emptying; Critical Illness; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12613001383752
• Lead Sponsor: Dr Yasmine Ali Abdelhamid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-17
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Fifty sedated and mechanically ventilated critically ill patients with stress hyperglycaemia will be recruited from the Intensive Care Unit at the Royal Adelaide Hospital. Stress hyperglycaemia will be defined as a single random blood glucose >10 mmol/L in a patient without a history of formally diagnosed type-1 or type-2 diabetes mellitus who has a glycated haemoglobin (HbA1c) <6.5%. Patients will be between the ages of 18 and 80 years, anticipated to remain ventilated for at least 24 hours and deemed suitable by the treating intensive care physician to receive intragastric enteral nutrition.

Exclusion Criteria

Exclusion criteria will comprise:
1. History of type-1 or type-2 diabetes mellitus
2. Pregnancy (a BHCG will be performed on all women of child-bearing age)
3. Haemoglobin <80g/L
4. Contraindication to enteral feeding
5. Previous surgery on the oesophagus, stomach or small intestine.
6. History of pancreatitis
7. Glycated haemoglobin (HbA1c) >/=6.5%
8. Prokinetics administered in the preceding 24 hour period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycaemic control which will be measured using a variety of mechanisms including: glycaemic penalty index, recording hypo and hyperglycaemic events, time in ideal range and assessing glycaemic variability.[Patients will be studies over a minimum of 18 hours and a maximum of 30 hours. ]

Secondary Outcome Measures

Name	Time	Method
Glucose absorption (3-OMG absorption)[Data will be collected for a minimum of 18 hours and a maximum of 30 hours];Gastric emptying via Scinitigraphy and 2D ultrasound[The study will be completed over a minimum of 18 hours and a maximum of 30 hours];Manometry/pH data will be assessed using basal LOS pressure, Gastro-oesophageal motility, reflux events and oesophageal pH[The study will be completed for a minimum of 18 hours and a maximum of 30 hours.];Oesophageal impedance via number of liquid and non-acid reflux episodes.[The study will be completed for a minimum of 18 hours and a maximum of 30 hours.];Plasma concentrations of GLP-1, GIP, Glucagon and C-peptide[The study will be completed over a minimum of 18 hours and a maximum of 30 hours];Superior mesenteric artery blood flow using doppler ultrasound[The study will be completed over a minimum of 18 hours and a maximum of 30 hours.]