None listed
Conditions
Brief summary
The purpose of this study is to determine the optimum dose of exogenous glucagon-like peptide-1 (GLP-1) with stepped administration; and evaluate the effects of GLP-1 on gastric emptying, mesenteric blood flow and glucose metabolism when compared to exogenous insulin.
Interventions
Intravenous GLP-1 at an initial dose of 1.2pmol.kg.min (10mL/h) and ‘placebo insulin’ (0.9% saline) commenced as per the Royal Adelaide Hospital unit protocol. The drug will be administered for a minimum of 18 hours and a maximum of 30 hours. The infusion will span Day 0 and Day 1 of the study (minimum of 18 hours, maximum 30 hours). Due to differences in the rate of gastric emptying throughout the day, the length of infusion on Day 0 will change depending on time of randomization so that scinti
Intravenous GLP-1 at an initial dose of 1.2pmol.kg.min (10mL/h) and ‘placebo insulin’ (0.9% saline) commenced as per the Royal Adelaide Hospital unit protocol. The drug will be administered for a minimum of 18 hours and a maximum of 30 hours. The infusion will span Day 0 and Day 1 of the study (minimum of 18 hours, maximum 30 hours). Due to differences in the rate of gastric emptying throughout the day, the length of infusion on Day 0 will change depending on time of randomization so that scintigraphy on Day 1 will be standardized to 9am. The GLP-1 rate is altered if the blood sugar remains above 10mmol/L in a stepped fashion (to 2.4 and 3.6 pmol/kg/min). Saline will be run as if insulin is being administered (1U/mL e.g if 2 units required, rate will be 2 ml/hr).
Sponsors
Dr Yasmine Ali Abdelhamid
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
Outcome results
None listed