Effect of 10mg Domperidone on Gastric Emptying of a High-fat Meal and Appetite Sensations in Healthy Adults

NCT ID: NCT01347814

Last Updated: 2011-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to determine whether domperidone was sufficient to accelerate gastric emptying of a high-fat solid meal and reduce satiety responses in a healthy adult population.

Detailed Description

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This study aims to investigate the effect of domperidone on gastric emptying and appetite sensations in healthy subjects. Domperidone is a dopamine 2 (D2) receptor antagonist with claims of gastrointestinal tract pro-kinetic activity. Accelerated gastric emptying (GE) may lead to reduced satiation, increased food intake and is associated with obesity and diabetes mellitus. It is hypothesized that domperidone will increase gastric emptying rate and reduce satiety responses to a high-fat meal.

The effect of acute oral administration of 10 mg domperidone on gastric emptying of a high-fat pancake test meal, and subjective appetite sensations by visual analogue scale will be measured for six hours postprandially in a randomized, placebo-controlled, single-blinded manner in 13 healthy subjects.

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Interventions

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Domperidone 10mg

10mg domperidone tablet 30 minutes before a test-meal.

Intervention Type DRUG

Placebo

Homeopathic (Sugar) pill-Placebo

Intervention Type DRUG

Other Intervention Names

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Motilium Homeopathic medicine; Silicea, 6c, Weleda, Derbyshire, UK

Eligibility Criteria

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Inclusion Criteria

* Healthy adults aged 18-40 years

Exclusion Criteria

* History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease
Minimum Eligible Age

10 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Irish Research Council

OTHER

Sponsor Role collaborator

University of Limerick

OTHER

Sponsor Role lead

Responsible Party

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University of Limerick

Principal Investigators

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Amir Shafat

Role: PRINCIPAL_INVESTIGATOR

University of Limerick

Locations

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Department of Physical Education & Sport Sciences, University of Limerick

Limerick, , Ireland

Site Status

Countries

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Ireland

References

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Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007 Sep;102(9):2036-45. doi: 10.1111/j.1572-0241.2007.01255.x. Epub 2007 May 3.

Reference Type BACKGROUND
PMID: 17488253 (View on PubMed)

Markey O, Shafat A. Does domperidone, a D2-antagonist alter gastric emptying rates and appetite sensations in healthy adults with high-fat meal? A block-randomised, single-blind placebo-controlled study. Ir J Med Sci. 2012 Jun;181(2):215-9. doi: 10.1007/s11845-011-0785-2. Epub 2011 Nov 29.

Reference Type DERIVED
PMID: 22124998 (View on PubMed)

Other Identifiers

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DompGastEmpt

Identifier Type: -

Identifier Source: org_study_id

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