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

This study has been completed.
Sponsor:
Collaborator:
Irish Research Council Science, Engineering and Technology (IRCSET)
Information provided by:
University of Limerick
ClinicalTrials.gov Identifier:
NCT01347814
First received: May 3, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Diabetes Mellitus
 Drug: Domperidone 10mg
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Does Domperidone, a D2-antagonist Alter Gastric Emptying Rates and Appetite Sensations in Healthy Adults?

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
Drug Information available for: Domperidone
U.S. FDA Resources

Further study details as provided by University of Limerick:

Primary Outcome Measures:
  • Gastric emptying half time [ Time Frame: 6.5 Hours post ingestion ] [ Designated as safety issue: No ]
    Determination of Gastric emptying of a high-fat test meal measured by octanoic acid breath test after acute administration of 10mg domperidone


Secondary Outcome Measures:
  • Appetite sensations [ Time Frame: 6.5 hours post ingestion ] [ Designated as safety issue: No ]
    Determination of appetite sensations associated with ingestion of a high-fat test meal by visual analogue scale after acute administration of 10mg domperidone


Enrollment: 13
Study Start Date: February 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Domperidone 10mg
    10mg domperidone tablet 30 minutes before a test-meal.
    Other Name: Motilium
    Drug: Placebo
    Homeopathic (Sugar) pill-Placebo
    Other Name: Homeopathic medicine; Silicea, 6c, Weleda, Derbyshire, UK
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   10 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults aged 18-40 years

Exclusion Criteria:

  • History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347814

Locations
Ireland
Department of Physical Education & Sport Sciences, University of Limerick
Limerick, Ireland
Sponsors and Collaborators
University of Limerick
Irish Research Council Science, Engineering and Technology (IRCSET)
Investigators
Principal Investigator: Amir Shafat University of Limerick
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amir Shafat/Dr, University of Limerick
ClinicalTrials.gov Identifier: NCT01347814     History of Changes
Other Study ID Numbers: DompGastEmpt
Study First Received: May 3, 2011
Last Updated: May 3, 2011
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University of Limerick:
Domperidone
gastric emptying
obesity
diabetes mellitus
Domperidone/pharmacology
 Pharmacologic Actions
Physiological Effects of Drugs
Gastrointestinal Agents
Humans

Additional relevant MeSH terms:
Pharmacologic Actions
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastrointestinal Agents
Domperidone
Physiological Effects of Drugs
Therapeutic Uses
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013