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Trial registered on ANZCTR


Registration number
ACTRN12612001040853
Ethics application status
Approved
Date submitted
26/09/2012
Date registered
28/09/2012
Date last updated
8/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Does pulsatile administration of glucagon-like peptide-1 (GLP-1) when compared to continuous infusion have a greater effect on insulin secretion and blood glucose lowering in healthy humans?
Scientific title
The effects of pulsatile, when compared to continuous, infusion of glucagon-like peptide-1 on insulin secretion and blood glucose in healthy humans
Secondary ID [1] 281306 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Blood Glucose 287512 0
Condition category
Condition code
Metabolic and Endocrine 287841 287841 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: 1ml bolus of glucagon-like peptide-1 (GLP-1)at 3.6 pmol/kg every 6 minutes and a continuous infusion of 0.9% isotonic saline (1 ml/min) both intravenously for 120min.

Subjects will be studied on three occasions sperated by a minimum of 3 days.
Intervention code [1] 285768 0
Treatment: Drugs
Comparator / control treatment
Control: continuous infusion of GLP-1 at 0.6 pmol/kg/min (1 ml/min) and a 1ml bolus of 0.9% isotonic saline every 6 minutes both intravenously for 120min.

Placebo: continuous infusion of 0.9% isotonic saline (1 ml/min) and a 1ml bolus of 0.9% isotonic saline every 6 minutes both intravenously for 120min.
Control group
Placebo

Outcomes
Primary outcome [1] 288060 0
To determine whether pulsatile administration of GLP-1 causes greater perturbations of insulin secretion when compared with continuous administration.
Timepoint [1] 288060 0
Insulin levels will be measured every minute for 120min
Secondary outcome [1] 299353 0
To determine whether pulsatile administration of GLP-1 has a more potent glucose-lowering effect when compared with continuous administration.
Timepoint [1] 299353 0
Glucose will be measured every minute for 120min

Eligibility
Key inclusion criteria
Healthy volunteers able to give informed consent
Minimum age
18 Years
Maximum age
35 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to give informed consent
History of diabetes
Women who are pregnant or lactating
History of pancreatitis
Haemoglobin <125g/L for women and <135g/L for men
Glycated haemoglobin (HbA1c) >6.0 %
Ferritin levels for women <10microgram/L and <20microgram/L for men
Estimated glomerular filtration rate < 60ml/min
Impaired liver function (ALT: >55 U/L; Albumin: <34g/l; ALP: >110 U/L; Bilirubin: >25 micro mol; GGT: >80U/L)
Blood donation within the previous 12 weeks
BMI <18.5 or >30kgm^2
Taking blood-glucose lowering drugs

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 recruited from our existing database of volunteers

The study is a randomised, double blind, double dummy, cross-over study. The randomisation will be performed by the Department of Pharmacy, Royal Adelaide Hospital and the randomisation schedule will be kept in a locked facility within the Department of Pharmacy and the investigators will have no access to the schedule during the study period. Once the peptide is reconstituted the study drug or placebo is packaged and labelled study drug. The investigator will receive the study drug from the pharmacy department and have no involvement in preparation of solution or randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1937 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7681 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 286063 0
Government body
Name [1] 286063 0
National Health and Medical Research Council (NHMRC)
Address [1] 286063 0
Level 5, 20 Allara Street
Canberra ACT 2601
Country [1] 286063 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital Intensive Care Unit
Address
Intensive Care Unit
Level 4 Royal Adelaide Hospital
North Terrace
Adelaide
5000 SA
Country
Australia
Secondary sponsor category [1] 284881 0
Individual
Name [1] 284881 0
Dr Adam Deane
Address [1] 284881 0
Intensive Care Unit
Level 4 Royal Adelaide Hospital
North Terrace
Adelaide
5000 SA
Country [1] 284881 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288116 0
Royal Adelaide Hospital Research Ethics Committe
Ethics committee address [1] 288116 0
Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 288116 0
Australia
Date submitted for ethics approval [1] 288116 0
24/04/2012
Approval date [1] 288116 0
26/09/2012
Ethics approval number [1] 288116 0

Summary
Brief summary
The purpose of this study is to determine the optimum administration method of glucagon-like peptide-1 (GLP-1), by evaluating whether pulsatile administration of GLP-1 causes greater insulin secretion and glucose lowering when compared with continuous administration.
Trial website
Trial related presentations / publications
The publication is currently in the process of being completed for submission to an international medical journal.
Public notes

Contacts
Principal investigator
Name 34760 0
Dr Adam Deane
Address 34760 0
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 34760 0
Australia
Phone 34760 0
+61 8 8222 4000
Fax 34760 0
Email 34760 0
adam.deane@adelaide.edu.au
Contact person for public queries
Name 18007 0
Dr Adam Deane
Address 18007 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 18007 0
Australia
Phone 18007 0
+61 8 8222 4000
Fax 18007 0
Email 18007 0
adam.deane@adelaide.edu.au
Contact person for scientific queries
Name 8935 0
Dr Adam Deane
Address 8935 0
Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country 8935 0
Australia
Phone 8935 0
+61 8 8222 4000
Fax 8935 0
Email 8935 0
adam.deane@adelaide.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary