ANZCTR - Registration

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gut hormone secretion

Condition category

Condition code

Metabolic and Endocrine

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]

Treatment: Other

Comparator / control treatment

intraduodenal infusion of isotonic saline will be used as the control treatment

Control group

Placebo

Outcomes

Primary outcome [1]

differences in the incremental area under the curve (iAUC) for plasma levels of ghrelin after hypertonic saline infusion, compared with control

Timepoint [1]

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]

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]

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]

differences in the incremental area under the curve (iAUC) for plasma levels of GLP-1 after hypertonic saline infusion, compared with control

Timepoint [2]

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]

differences in the incremental area under the curve (iAUC) for plasma levels of GIP after hypertonic saline infusion, compared with control

Timepoint [3]

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]

differences in the incremental area under the curve (iAUC) for plasma levels of CCK after hypertonic saline infusion, compared with control

Timepoint [4]

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]

differences in the incremental area under the curve (iAUC) for plasma levels of secretin after hypertonic saline infusion, compared with control

Timepoint [5]

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]

difference in energy intake (by weighing of food consumed at the buffet meal) after intraduodenal infusion of hypertonic and isotonic saline

Timepoint [6]

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

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]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Country [1]

Australia

Primary sponsor type

Hospital

Name

Royal Adelaide Hospital

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital Human Research Ethics Committee

Ethics committee address [1]

Level 4, Women’s Health Centre Royal Adelaide Hospital North Terrace Adelaide, South Australia, 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/06/2016

Approval date [1]

17/06/2016

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

Dr Tongzhi Wu

Address

Discipline of Medicine, Royal Adelaide Hospital, Level 6, Eleanor Harrald Building, Frome Road, Adelaide, SA, 5000.

Country

Australia

Phone

+61 8 8222 5038

Email

[email protected]

Contact person for public queries

Name

Tongzhi Wu

Address

Discipline of Medicine, Royal Adelaide Hospital, Level 6, Eleanor Harrald Building, Frome Road, Adelaide, SA, 5000.

Country

Australia

Phone

+61 8 8222 5038

Email

[email protected]

Contact person for scientific queries

Name

Tongzhi Wu

Address

Discipline of Medicine, Royal Adelaide Hospital, Level 6, Eleanor Harrald Building, Frome Road, Adelaide, SA, 5000.

Country

Australia

Phone

+61 8 8222 5038

Email

[email protected]

Trial Review

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