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Trial registered on ANZCTR


Registration number
ACTRN12616001668493
Ethics application status
Approved
Date submitted
30/11/2016
Date registered
5/12/2016
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of osmolality on gut hormone secretion
Scientific title
Effect of hyperosmolar duodenal infusions on ghrelin secretion in healthy individuals
Secondary ID [1] 290662 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut hormone secretion 301189 0
Condition category
Condition code
Metabolic and Endocrine 300942 300942 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following enrolment, each subject will be studied on two occasions, separated by at leaste 7 days, in a double-blind, randomised order. On each study day, following correct positioning of the intraduodenal catheter, 4 baseline samples will be drawn (at t = -45, -30, -15 and 0 min), followed by an intraduodenal infusion of either isotonic saline (300mOsm) or hypertonic saline (1500mOsm) at a rate of 4 ml/min for 45 min (t=0-45 min). Blood samples will be collected for another 3 hours (at t = 15, 30, 45, 60, 75, 90, 120 and 180 min). At t = 180 min, the intraduodenal catheter will be removed, and a cold buffet meal will be given for evaluation of energy intake.
Intervention code [1] 296541 0
Treatment: Other
Comparator / control treatment
intraduodenal infusion of isotonic saline will be used as the control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 300366 0
differences in the incremental area under the curve (iAUC) for plasma levels of ghrelin after hypertonic saline infusion, compared with control
Timepoint [1] 300366 0
at t = -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min, where t = -45 min is when the intraduodenal catheter is correctly positioned, t = 0 is the start of intraduodenal infusion of hypertonic or isotonic saline, t = 45 min is the end of intrauodenal infusion, and t = 180 min is the end of observation.
Secondary outcome [1] 329797 0
differences in the incremental area under the curve (iAUC) for appetite perception score using visual analogue scale after hypertonic saline infusion, compared with control
Timepoint [1] 329797 0
at t = -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min, where t = -45 min is when the intraduodenal catheter is correctly positioned, t = 0 is the start of intraduodenal infusion of hypertonic or isotonic saline, t = 45 min is the end of intrauodenal infusion, and t = 180 min is the end of observation.
Secondary outcome [2] 329798 0
differences in the incremental area under the curve (iAUC) for plasma levels of GLP-1 after hypertonic saline infusion, compared with control
Timepoint [2] 329798 0
at t = -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min, where t = -45 min is when the intraduodenal catheter is correctly positioned, t = 0 is the start of intraduodenal infusion of hypertonic or isotonic saline, t = 45 min is the end of intrauodenal infusion, and t = 180 min is the end of observation.
Secondary outcome [3] 329799 0
differences in the incremental area under the curve (iAUC) for plasma levels of GIP after hypertonic saline infusion, compared with control
Timepoint [3] 329799 0
at t = -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min, where t = -45 min is when the intraduodenal catheter is correctly positioned, t = 0 is the start of intraduodenal infusion of hypertonic or isotonic saline, t = 45 min is the end of intrauodenal infusion, and t = 180 min is the end of observation.
Secondary outcome [4] 329800 0
differences in the incremental area under the curve (iAUC) for plasma levels of CCK after hypertonic saline infusion, compared with control
Timepoint [4] 329800 0
at t = -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min, where t = -45 min is when the intraduodenal catheter is correctly positioned, t = 0 is the start of intraduodenal infusion of hypertonic or isotonic saline, t = 45 min is the end of intrauodenal infusion, and t = 180 min is the end of observation.
Secondary outcome [5] 329801 0
differences in the incremental area under the curve (iAUC) for plasma levels of secretin after hypertonic saline infusion, compared with control
Timepoint [5] 329801 0
at t = -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min, where t = -45 min is when the intraduodenal catheter is correctly positioned, t = 0 is the start of intraduodenal infusion of hypertonic or isotonic saline, t = 45 min is the end of intrauodenal infusion, and t = 180 min is the end of observation.
Secondary outcome [6] 329802 0
difference in energy intake (by weighing of food consumed at the buffet meal) after intraduodenal infusion of hypertonic and isotonic saline
Timepoint [6] 329802 0
during t =180 and 210 min, where t = 180 min is the start of the buffet meal, and t = 210 min is the end of buffet meal.

Eligibility
Key inclusion criteria
* Body mass index (BMI) 20 - 25 kg/m2
* Males (to avoid the effect of the menstrual cycle on gut hormone secretion)
* Glycated haemoglobin (HbA1c) less than or equal to 6.0%
* Haemoglobin above the lower limit of the normal range (i.e. greater than 135g/L), and ferritin above the lower limit of normal (i.e. greater than 10microg/L)
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Use of any medication that may influence BP, gastrointestinal motor function, body weight or appetite (e.g. antihypertensive drugs, domperidone and cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St. John's Wort etc.)
* Evidence of drug abuse, consumption of tobacco in any form or daily consumption of more than 20 g alcohol
* History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery (other than uncomplicated appendectomy)
* Restrained eaters [score greater than or equal to 12 on the eating restraint component of the Three-Factor Eating Questionnaire
* Other significant illness, including epilepsy, cardiovascular or respiratory disease
* Autonomic nerve damage (as assessed by standardised cardiovascular reflex tests
* Impaired renal or liver function (as assessed by calculated creatinine clearance less than 90 mL/min or abnormal liver function tests (greater than 2 times upper limit of normal range))
* Donation of blood within the previous 3 months
* Participation in any other research studies within the previous 3 months
* Inability to give informed consent
* Allergy to local anaesthetic
* Vegetarians

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation 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

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies, we anticipate that 18 participants will provide 80% power (at a = 0.05) to detect a 40% decrease in the incremental area under the curve (iAUC) for plasma ghrelin.
The primary and secondary endpoints will be evaluated using paired Student's t-test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/01/2017
Actual
15/03/2017
Date of last participant enrolment
Anticipated
10/10/2017
Actual
8/05/2017
Date of last data collection
Anticipated
30/10/2017
Actual
30/06/2017
Sample size
Target
18
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 7035 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 14767 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 295091 0
Government body
Name [1] 295091 0
NHMRC
Country [1] 295091 0
Australia
Primary sponsor type
Hospital
Name
Royal Adelaide Hospital
Address
Level 6, Eleanor Harrald Building
Frome Road
Royal Adelaide Hospital
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 293912 0
None
Name [1] 293912 0
Address [1] 293912 0
Country [1] 293912 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296444 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 296444 0
Level 4, Women’s Health Centre Royal Adelaide Hospital North Terrace Adelaide, South Australia, 5000
Ethics committee country [1] 296444 0
Australia
Date submitted for ethics approval [1] 296444 0
10/06/2016
Approval date [1] 296444 0
17/06/2016
Ethics approval number [1] 296444 0
R20160611

Summary
Brief summary
The human gut secretes a number of hormones to regulate food intake and blood sugar. Ghrelin is a hormone secreted from the stomach before meals, which promotes food intake. Glucagon-like peptide-1 (GLP-1) is secreted from the small and large intestines after meals, and is known to suppress food intake and improve blood sugar control. In this trial, we want to investigate whether saline solutions administered into the small intestine will affect the secretion of ghrelin and GLP-1, and the sensation of hunger and satiety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70874 0
Dr Tongzhi Wu
Address 70874 0
Discipline of Medicine, Royal Adelaide Hospital, Level 6, Eleanor Harrald Building, Frome Road, Adelaide, SA, 5000.
Country 70874 0
Australia
Phone 70874 0
+61 8 8222 5038
Fax 70874 0
Email 70874 0
[email protected]
Contact person for public queries
Name 70875 0
Tongzhi Wu
Address 70875 0
Discipline of Medicine, Royal Adelaide Hospital, Level 6, Eleanor Harrald Building, Frome Road, Adelaide, SA, 5000.
Country 70875 0
Australia
Phone 70875 0
+61 8 8222 5038
Fax 70875 0
Email 70875 0
[email protected]
Contact person for scientific queries
Name 70876 0
Tongzhi Wu
Address 70876 0
Discipline of Medicine, Royal Adelaide Hospital, Level 6, Eleanor Harrald Building, Frome Road, Adelaide, SA, 5000.
Country 70876 0
Australia
Phone 70876 0
+61 8 8222 5038
Fax 70876 0
Email 70876 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
SourceTitleYear of PublicationDOI
EmbaseHyperosmolar duodenal saline infusion lowers circulating ghrelin and stimulates intestinal hormone release in young men.2018https://dx.doi.org/10.1210/jc.2018-00699
N.B. These documents automatically identified may not have been verified by the study sponsor.