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Gastric Emptying Validation Pilot Study (MRI Val)

NCT05765123 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2023-07-13

No results posted yet for this study

Summary

The primary aim of this study is to assess (in healthy volunteers) the rate at which a glucose drink leaves the stomach by sequential magnetic resonance imaging (MRI) of the stomach contents using a 0.5 tesla upright MRI scanner, and comparing with the rate derived from a standard method which uses a stable isotope tracer and breath testing. The main question it aims to answer are:

* Do MRI derived images of stomach contents at low magnetic field (0.5 Tesla) have sufficient resolution to provide a reproducible assessment of gastric emptying
* What is the agreement and relationship between the rate of gastric emptying determined from the 2 methods Participants will be asked to attend the imaging centre on one occasion in the morning after fasting from midnight and to sit within an upright MRI scanner for a period of approximately 140 minutes. Images of their stomach will be taken before and for 2 hours after consuming a drink containing glucose and a small amount of sodium acetate which contains a heavier form of carbon. Before each image is taken, participants will be asked to exhale into a 500ml bag to collect a breath sample.

Conditions

  • Gastrointestinal Dysfunction

Interventions

DIAGNOSTIC_TEST

Oral glucose tolerance test

A drink containing 75g of glucose together with 150mg carbon-13 sodium acetate in 300ml water

Sponsors & Collaborators

  • University of Nottingham

    lead OTHER

Principal Investigators

  • Luca Marciani, PhD · University of Nottingham

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-03-28
Completion
2023-03-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05765123 on ClinicalTrials.gov