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Diabetes MellitusNCT01347814

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

A study testing Domperidone 10mg in people with Diabetes Mellitus, run by University of Limerick at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus
What is being tested?
Domperidone 10mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
13 participants
Where
1 siteIreland
Study dates
Feb 2008to Apr 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy adults aged 18-40 years

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Ireland1 site

  • Department of Physical Education & Sport Sciences, University of Limerick

    Limerick

Other trials in Ireland

About this study

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

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.

Read the 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.

Being tested
Domperidone 10mg, Placebo
Keywords
Domperidone, gastric emptying, obesity, diabetes mellitus, Domperidone/pharmacology, Pharmacologic Actions, Physiological Effects of Drugs, Gastrointestinal Agents, Humans
Medical subject headings
Diabetes Mellitus, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Domperidone 10mgDrug

    Also called Motilium

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

  • PlaceboDrug

    Also called Homeopathic medicine; Silicea, 6c, Weleda, Derbyshire, UK

    Homeopathic (Sugar) pill-Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6.5 Hours post ingestion

Secondary outcomes (1)

  1. 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

    Measured: 6.5 hours post ingestion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2011 (estimated)
  2. Study startFeb 2008
  3. Primary completionApr 2010
  4. Study completionApr 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01347814
Sponsor's protocol ID
DompGastEmpt
Status last verified
May 2011
First submitted
3 May 2011
Last updated
4 May 2011
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 17488253

  • 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.

    PubMed 22124998

Questions about this trial

What is this clinical trial studying?

A study testing Domperidone 10mg in people with Diabetes Mellitus, run by University of Limerick at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gastric emptying half time (time frame: 6.5 Hours post ingestion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01347814, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2011.

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