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

Diabetes Mellitus Clinical Trial

Official title:

Does Domperidone, a D2-antagonist Alter Gastric Emptying Rates and Appetite Sensations in Healthy Adults?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01347814
• Other study ID #: DompGastEmpt
• Status: Completed
• Phase: N/A
• First received: May 3, 2011
• Last updated: May 3, 2011
• Start date: February 2008
• Est. completion date: April 2010

Study information

• Verified date: May 2011
• Source: University of Limerick
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy adults aged 18-40 years

Exclusion Criteria:

• History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Domperidone 10mg
10mg domperidone tablet 30 minutes before a test-meal.
• Placebo
Homeopathic (Sugar) pill-Placebo

Locations

Country	Name	City	State
Ireland	Department of Physical Education & Sport Sciences, University of Limerick	Limerick

Sponsors (2)

Lead Sponsor	Collaborator
University of Limerick	Irish Research Council

Country where clinical trial is conducted

Ireland, 

References & Publications (1)

Reddymasu SC, Soykan I, McCallum RW. Domperidone: review of pharmacology and clinical applications in gastroenterology. Am J Gastroenterol. 2007 Sep;102(9):2036-45. Epub 2007 May 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying half time	Determination of Gastric emptying of a high-fat test meal measured by octanoic acid breath test after acute administration of 10mg domperidone	6.5 Hours post ingestion	No
Secondary	Appetite sensations	Determination of appetite sensations associated with ingestion of a high-fat test meal by visual analogue scale after acute administration of 10mg domperidone	6.5 hours post ingestion	No