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Trial registered on ANZCTR


Registration number
ACTRN12614000815662
Ethics application status
Approved
Date submitted
16/07/2014
Date registered
31/07/2014
Date last updated
7/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective randomised double-blind, double-dummy, placebo-controlled crossover study to determine whether Glucagon-like peptide-1 (GLP-1) stimulates or suppresses pancreatic exocrine function in health.
Scientific title
A prospective randomised double-blind, double-dummy, placebo-controlled crossover study on 15 healthy male participants to determine whether Glucagon-like peptide-1 (GLP-1) stimulates or suppresses pancreatic exocrine function in health.
Secondary ID [1] 284959 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperglycaemia 292451 0
Type 2 Diabetes 292452 0
Critical Illness-induced hyperglycaemia 292453 0
Condition category
Condition code
Metabolic and Endocrine 292769 292769 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IV GLP-1 (1.2 pmol/kg/min) infusion or placebo will be administrated to participants over 2 visits. Participants will receive a second IV containing either Secretin (75ng/kg/hr) and CCK (20ng/kg/hr) or placebo over 2 visits. Adherence of intervention will be monitored by both the clinical trial pharmacy and the researchers in the study to ensure the participants receive the correct treatment/placebo on any given trial day. Participants will be studied over 4 occasions, separated by at least 4 days.
Intervention code [1] 289798 0
Treatment: Drugs
Comparator / control treatment
On visits when participants aren't receiving GLP-1 or Secretin + CCK they will receive human albumin and saline, respectively.
Control group
Placebo

Outcomes
Primary outcome [1] 292627 0
To determine whether GLP-1 acutely stimulates pancreatic exocrine function in health. This will be assessed by peak duodenal bicarbonate concentration and pancreatic bicarbonate output.

Peak duodenal amylase concentrations and amylase concentration area under the curve.
Timepoint [1] 292627 0
Duodenal Aspirates will be collected every 15 mins for an hour to assess pancreatic function
Secondary outcome [1] 309378 0
Changes in plasma amylase and lipase
Timepoint [1] 309378 0
Bloods will be taken every 15 mins for an hour.

Eligibility
Key inclusion criteria
Healthy Male volunteers between the ages of 18-35
Minimum age
18 Years
Maximum age
35 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to give informed consent
History of diabetes
History of pancreatitis
Lipase level >210 U/L
Amylase level > 110 U/L
Estimated glomerular filtration rate < 60ml/min
Impared liver function (ALT >55 U/L; Albumin <34g/l, ALP >110 U/L; Bilirubin >25 umol; GGT > 80 U/L)
Haemoglobin <135g/L
HbA1c >6%
Body Mass Index >32kg/m2
Smoking > 10 cigarettes/day
Alcohol consumption >20g/day
Volunteers who have donated blood in the preceding 3 months
Female volunteers of child bearing age
Suffer from any chronic medical conditions such as (but not limited to) heart failure, ischaemic heart disease, chronic lung disease, autonomic dysfunction resulting from any cause active or previously treated malignancy, chronic infections (e.g viral hepatitis and HIV)
Suffered from any acute medical illnesses during the 4 week period before recruitment
Contraindications to any of the drugs used in this study (e.g. known hypersensitivity)
Gallstone(s) visualised on ultrasound at the screening visit.

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)
Participants will be enrolled using an enrollment number and data will be sent to the Royal Adelaide Hospital clinical trials pharmacy department to be randomised for drug treatments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed by the clinical trials pharmacy department using a randomisation table created by computer software.
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Sample size was generated from previous studies assessing secretin stimulation on chronic pancreatitis. However, due to the novelty of the study there are no directly related studies.

Outcome variables will be analysed using an appropriate statistical methods.

Recruitment
Recruitment status
Not yet recruiting
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] 2723 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8441 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 289590 0
Government body
Name [1] 289590 0
National Health and Medical Research Council Grant
Address [1] 289590 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Australia
Country [1] 289590 0
Australia
Primary sponsor type
Individual
Name
Dr Adam Deane
Address
ICU Research
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000
Country
Australia
Secondary sponsor category [1] 288274 0
None
Name [1] 288274 0
Address [1] 288274 0
Country [1] 288274 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291325 0
Royal Adelaide Hospital Ethics Committee
Ethics committee address [1] 291325 0
North Terrace
Adelaide
SA 5000
Ethics committee country [1] 291325 0
Australia
Date submitted for ethics approval [1] 291325 0
Approval date [1] 291325 0
11/07/2014
Ethics approval number [1] 291325 0
140604

Summary
Brief summary
OUTCOMES

The primary outcome measures are
*peak duodenal bicarbonate concentration and pancreatic bicarbonate output (bicarbonate volume times bicarbonate concentration)
*peak duodenal amylase concentration and amylase concentration area under the curve (time equals 0 to 60 minutes)

Secondary outcome measures are
*Plasma concentrations of amylase and lipase
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49850 0
Prof Marianne Chapman
Address 49850 0
Royal Adelaide Hospital
North Tce
Adelaide 5000
South Australia
Country 49850 0
Australia
Phone 49850 0
+6188222 4624
Fax 49850 0
Email 49850 0
Marianne.Chapman@sa.gov.au
Contact person for public queries
Name 49851 0
Prof Marianne Chapman
Address 49851 0
Royal Adelaide Hospital
North Tce
Adelaide 5000
South Australia
Country 49851 0
Australia
Phone 49851 0
+6188222 4624
Fax 49851 0
Email 49851 0
Marianne.Chapman@sa.gov.au
Contact person for scientific queries
Name 49852 0
Dr Marianne Chapman
Address 49852 0
Royal Adelaide Hospital
North Tce
Adelaide 5000
South Australia
Country 49852 0
Australia
Phone 49852 0
+6188222 4624
Fax 49852 0
Email 49852 0
Marianne.Chapman@sa.gov.au

No information has been provided regarding IPD availability
Summary results
No Results