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Trial registered on ANZCTR


Registration number
ACTRN12613001383752
Ethics application status
Approved
Date submitted
17/07/2013
Date registered
17/12/2013
Date last updated
24/06/2021
Date data sharing statement initially provided
24/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 282841 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Glycaemic control 289649 0
Gastric emptying 289650 0
Critical Illness 289675 0
Condition category
Condition code
Metabolic and Endocrine 289966 289966 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 287533 0
Treatment: Drugs
Comparator / control treatment
Intravenous ‘placebo GLP-1’ (0.9% saline; run at the appropriate rate depending on the blood sugar e.g 10ml/hr) and insulin (actrapid; Novo Nordisk Pharmaceuticals Pty Ltd; 1 Unit per mL) as per the Royal Adelaide Hospital unit protocol. Study drugs are 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.
Control group
Active

Outcomes
Primary outcome [1] 290019 0
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.
Timepoint [1] 290019 0
Patients will be studies over a minimum of 18 hours and a maximum of 30 hours.
Secondary outcome [1] 303783 0
Glucose absorption (3-OMG absorption)
Timepoint [1] 303783 0
Data will be collected for a minimum of 18 hours and a maximum of 30 hours
Secondary outcome [2] 303792 0
Gastric emptying via Scinitigraphy and 2D ultrasound
Timepoint [2] 303792 0
The study will be completed over a minimum of 18 hours and a maximum of 30 hours
Secondary outcome [3] 303793 0
Manometry/pH data will be assessed using basal LOS pressure, Gastro-oesophageal motility, reflux events and oesophageal pH
Timepoint [3] 303793 0
The study will be completed for a minimum of 18 hours and a maximum of 30 hours.
Secondary outcome [4] 303794 0
Oesophageal impedance via number of liquid and non-acid reflux episodes.
Timepoint [4] 303794 0
The study will be completed for a minimum of 18 hours and a maximum of 30 hours.
Secondary outcome [5] 303795 0
Plasma concentrations of GLP-1, GIP, Glucagon and C-peptide
Timepoint [5] 303795 0
The study will be completed over a minimum of 18 hours and a maximum of 30 hours
Secondary outcome [6] 303796 0
Superior mesenteric artery blood flow using doppler ultrasound
Timepoint [6] 303796 0
The study will be completed over a minimum of 18 hours and a maximum of 30 hours.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be given an enrollment number and randomised through the clinical trials pharmacy department
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed using a randomisation table from a software program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
The sample size calculation was based on previous studies similar in nature to this study (both in results required and patients studied). We anticipate up to 20% of subjects to dropout (weaned from mechanical ventilation, commenced on comfort care etc.) and 40 completed subjects are required for adequate power of this parallel study.

The findings from the study will be analysed using parametric and/or non-parametric approaches as appropriate based on distribution of data. Results will be published in a peer-reviewed journal.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
30/03/2016
Actual
Date of last participant enrolment
Anticipated
30/12/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1328 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7170 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 287626 0
Government body
Name [1] 287626 0
National Health and Medical Research Council Grant
Country [1] 287626 0
Australia
Primary sponsor type
Individual
Name
Dr Yasmine Ali Abdelhamid
Address
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 286370 0
Individual
Name [1] 286370 0
Dr Adam Deane
Address [1] 286370 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide, SA 5000
Country [1] 286370 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289597 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 289597 0
Ethics committee country [1] 289597 0
Australia
Date submitted for ethics approval [1] 289597 0
Approval date [1] 289597 0
04/07/2013
Ethics approval number [1] 289597 0
130613

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41454 0
Dr Yasmine Ali Abdelhamid
Address 41454 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 41454 0
Australia
Phone 41454 0
61882224624
Fax 41454 0
Email 41454 0
yasmineaa@hotmail.com
Contact person for public queries
Name 41455 0
Yasmine Ali Abdelhamid
Address 41455 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 41455 0
Australia
Phone 41455 0
61882224624
Fax 41455 0
Email 41455 0
yasmineaa@hotmail.com
Contact person for scientific queries
Name 41456 0
Yasmine Ali Abdelhamid
Address 41456 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 41456 0
Australia
Phone 41456 0
61882224624
Fax 41456 0
Email 41456 0
yasmineaa@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.