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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:
ClinicalTrials.gov Identifier:
NCT01347814
First Posted: May 4, 2011
Last Update Posted: May 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Irish Research Council
Information provided by:
University of Limerick
  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 (Participant)
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:


Further study details as provided by University of Limerick:

Primary Outcome Measures:
  • Gastric emptying half time [ Time Frame: 6.5 Hours post ingestion ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347814


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

Publications:
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
First Submitted: May 3, 2011
First Posted: May 4, 2011
Last Update Posted: May 4, 2011
Last Verified: May 2011

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:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Domperidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action


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