Effect of osmolality on gut hormone secretion

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001668493
• Date of registration: 05/12/2016
• Prospective Registration: Yes
• Primary sponsor: Royal Adelaide Hospital
• Public title: Effect of osmolality on gut hormone secretion
• Scientific title: Effect of hyperosmolar duodenal infusions on ghrelin secretion in healthy individuals
• Date of first enrolment: 15/03/2017
• Target sample size: 18
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001668493.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Tongzhi Wu

• Name: Dr Tongzhi Wu

Key inclusion & exclusion criteria

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)

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


Age minimum: 18 Years
Age maximum: 55 Years
Gender: Males

Health Condition(s) or Problem(s) studied

Gut hormone secretion;
Gut hormone secretion

Metabolic and Endocrine - Normal metabolism and endocrine development and function

Intervention(s)

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.

Primary Outcome(s)

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

differences in the incremental area under the curve (iAUC) for appetite perception score using visual analogue scale after hypertonic saline infusion, compared with control
[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.
]

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

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

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

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

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

None

Source(s) of Monetary Support

NHMRC

Ethics review

Status: Approved
Approval date:
Contact:

Royal Adelaide Hospital Human Research Ethics Committee