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Trial registered on ANZCTR

Registration number

ACTRN12619000707167

Ethics application status

Approved

Date submitted

7/05/2019

Date registered

10/05/2019

Date last updated

21/10/2021

Date data sharing statement initially provided

10/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Effects of intraduodenal versus intragastric administration of quinine on gut function in healthy, lean volunteers.

Scientific title

Effects of intraduodenal versus intragastric administration of quinine on gut and gluco-regulatory hormone release, antropyloroduodenal motility, blood glucose concentrations and appetite perceptions, in healthy, lean volunteers.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Obesity

Type 2 Diabetes

Healthy human gastrointestinal physiology

Condition category

Condition code

Diet and Nutrition

Obesity

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Subjects will receive in randomised, double-blind fashion, a 600mg bolus administration of quinine either intraduodenally or intragastrically on 2 separate visits. Each visit will last 5hrs in duration, and will be separated by 3-7 days. Visits will be carried out in the Adelaide Medical School, University of Adelaide, by staff members trained in the required clinical research facilities.

Subjects will consume a standardised dinner meal, a 400g McCain's beef lasagne, the night before both study visits by no later than 7pm. After fasting for 14 hours overnight and refraining from alcohol and exercise for 24 hours, subjects will arrive at the clinical research facility by 8:30am. Upon arrival, subjects will be intubated with a 17-channel manometric catheter (Dentsleeve, Mui Scientific) that will be inserted through an anaesthetised nostril and allowed to pass through the stomach and into the duodenum by peristalsis. The manometric catheter consists of 16 side holes spaced at 1.5 cm intervals, measuring pressures in the antrum, pylorus, and duodenum (APD pressures). The most proximal antral channel (with the side hole positioned approximately 9cm proximal to the pylorus when the catheter is in position) is used for intragastric administration. An additional channel (with the side hole positioned approximately 14 cm distal to the pylorus when the catheter is in position) is used for intraduodenal administration. The correct positioning of the catheter will be maintained by continuous measurement of the transmucosal potential difference (TMPD) between the most distal antral channel and the most proximal duodenal channel. All manometric channels will be perfused with degassed, distilled water, except for the two TMPD channels, which will be perfused with degassed 0.9% saline, at 0.15 ml/min. An intravenous cannula will be placed into a right forearm vein for regular blood sampling to measure plasma hormone concentrations. Once the catheter has been positioned correctly, fasting motility will be monitored continuously, and immediately after the end of phase III activity of the fasting migrating motor complex (MMC), during a period of motor quiescence (t=-10 - 0 min), a 9 ml venous blood sample (baseline) will be taken, and the subject will complete a 100mm visual analogue scale questionnaire (VAS) to assess appetite-related perceptions (fullness, hunger, etc.) and GI symptoms (nausea and bloating). At t = -1 min, either the intraduodenal or intragastric bolus of quinine will be administered and another blood sample and VAS questionnaire will be taken immediately after administration. Regular 9ml venous blood samples will be taken throughout the study and additional VAS completed. A total of 90ml of blood will be taken on each study day (180ml over both study visits).

Intervention code [1]

Treatment: Other

Comparator / control treatment

Intragastric administration of 600mg bolus of quinine

Control group

Active

Outcomes

Primary outcome [1]

Plasma concentrations of gluco-regulatory and gut hormones (Insulin, GLP-1, CCK, glucagon, ghrelin, PYY).
This outcome is of an exploratory nature so that specific gastrointestinal hormones to be measured may be decided upon based on the effect of the intervention on this and other outcomes, therefore, this is a composite outcome.

Timepoint [1]

Samples will be collected at t = -10, 0 , 10, 20 , 30 , 45, 60 , 75 , 90, 120 min, where t = -10 is prior to quinine administration and t = 0 is immediately post-administartion.

Primary outcome [2]

Antropyloroduodenal motility (number of antral, duodenal and isolated pyloric pressure waves, and basal pyloric pressure) will be measured using a 17-channel manometric assembly (Dentsleeve, Mui Scientific).
This outcome is of an exploratory nature so that specific motility parameters to be measured may be decided upon based on the effect of the intervention on this and other outcomes, therefore, this is a composite outcome.

Timepoint [2]

Baseline (t = -10 - 0) and after administration (t = 0 -120).

Secondary outcome [1]

Blood glucose concentrations.

Timepoint [1]

Samples will be collected at t = -10, 0 , 10, 20 , 30 , 45, 60 , 75 , 90, 120 min.

Secondary outcome [2]

Measure satiety using a 100mm visual analogue scale questionnaire.

Timepoint [2]