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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?
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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
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Secondary ID [1]
281306
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Blood Glucose
287512
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Condition category
Condition code
Metabolic and Endocrine
287841
287841
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0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
285768
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Treatment: Drugs
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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.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To determine whether pulsatile administration of GLP-1 causes greater perturbations of insulin secretion when compared with continuous administration.
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Assessment method [1]
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Timepoint [1]
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Insulin levels will be measured every minute for 120min
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Secondary outcome [1]
299353
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To determine whether pulsatile administration of GLP-1 has a more potent glucose-lowering effect when compared with continuous administration.
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Assessment method [1]
299353
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Timepoint [1]
299353
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Glucose will be measured every minute for 120min
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Eligibility
Key inclusion criteria
Healthy volunteers able to give informed consent
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Minimum age
18
Years
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Maximum age
35
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer generated
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/01/2013
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Actual
5/04/2013
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Date of last participant enrolment
Anticipated
1/07/2013
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Actual
16/08/2013
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
12
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
1937
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
7681
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
286063
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Government body
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Name [1]
286063
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National Health and Medical Research Council (NHMRC)
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Address [1]
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Level 5, 20 Allara Street
Canberra ACT 2601
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Country [1]
286063
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Australia
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Primary sponsor type
Hospital
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Name
Royal Adelaide Hospital Intensive Care Unit
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Address
Intensive Care Unit
Level 4 Royal Adelaide Hospital
North Terrace
Adelaide
5000 SA
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Country
Australia
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Secondary sponsor category [1]
284881
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Individual
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Name [1]
284881
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Dr Adam Deane
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Address [1]
284881
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Intensive Care Unit
Level 4 Royal Adelaide Hospital
North Terrace
Adelaide
5000 SA
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Country [1]
284881
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288116
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Royal Adelaide Hospital Research Ethics Committe
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Ethics committee address [1]
288116
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Level 3
Hanson Institute
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
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Ethics committee country [1]
288116
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Australia
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Date submitted for ethics approval [1]
288116
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24/04/2012
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Approval date [1]
288116
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26/09/2012
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Ethics approval number [1]
288116
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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.
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Trial website
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Trial related presentations / publications
The publication is currently in the process of being completed for submission to an international medical journal.
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Public notes
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Contacts
Principal investigator
Name
34760
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Dr Adam Deane
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Address
34760
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ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
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Country
34760
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Australia
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Phone
34760
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+61 8 8222 4000
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Fax
34760
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Email
34760
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[email protected]
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Contact person for public queries
Name
18007
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Dr Adam Deane
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Address
18007
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Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
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Country
18007
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Australia
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Phone
18007
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+61 8 8222 4000
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Fax
18007
0
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Email
18007
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[email protected]
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Contact person for scientific queries
Name
8935
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Dr Adam Deane
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Address
8935
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Intensive Care Unit
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
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Country
8935
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Australia
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Phone
8935
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+61 8 8222 4000
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Fax
8935
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Email
8935
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
The insulinotropic effect of pulsatile compared with continuous intravenous delivery of GLP-1.
2016
https://dx.doi.org/10.1007/s00125-016-3878-7
N.B. These documents automatically identified may not have been verified by the study sponsor.
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