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

NCT01347814 | Completed

• 1 other identifier: DompGastEmpt
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Keywords

Domperidone; gastric emptying; obesity; diabetes mellitus; Domperidone/pharmacology; Pharmacologic Actions; Physiological Effects of Drugs; Gastrointestinal Agents; Humans

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Appetite sensations

  6.5 hours post ingestion

Interventions

Domperidone 10mg DRUG

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

Also known as: Motilium

Placebo DRUG

Homeopathic (Sugar) pill-Placebo

Also known as: Homeopathic medicine; Silicea, 6c, Weleda, Derbyshire, UK

Eligibility Criteria

• Age: 10 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy adults aged 18-40 years

You may not qualify if:

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

Sponsors & Collaborators

• University of Limerick: lead
• Irish Research Council: collaborator

Study Sites (1)

Department of Physical Education & Sport Sciences, University of Limerick

Limerick, Ireland

Location

Related Publications (2)

• 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.

  PMID: 17488253 BACKGROUND

• 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.

  PMID: 22124998 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Obesity

Interventions

Domperidone; Homeopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Complementary Therapies; Therapeutics

Study Officials

• Amir Shafat

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 3, 2011
• First Posted: May 4, 2011
• Study Start: February 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: May 4, 2011

Record last verified: 2011-05

Locations

IE (1)