Gastric Emptying Validation Pilot Study (MRI Val)

NCT05765123 | Completed

• 1 other identifier: 40-0822
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gastric emptying; Magnetic resonance imaging; '13-C acetate' breath test

Outcome Measures

Primary Outcomes (2)

• MRI gastric emptying rate (T50)

  Gastric emptying rate (ml/min) derived from the decrease in volume of gastric contents

  assessment made over 120 minutes (timepoints from 0 minutes to 120 minutes after consuming test drink)

• 13-Carbon labelled Sodium Acetate Breath test gastric emptying rate (T50)

  Gastric emptying rate derived (ml/min) from the rate of appearance of carbon 13 labelled CO2 in the breath

  assessment made over 120 minutes (timepoints from 0 minutes to 120 minutes after consuming test drink)

Secondary Outcomes (2)

• Volume of gastric contents

  assessed at timepoints from 0 minutes to 120 minutes after consuming the test drink (timepoints 0,5,10,15,20,25,30,35,40,45,50,55,60,70,80,90,100,110,and 120 minutes)

• Carbon 13-enrichment of breath CO2

  assessed at timepoints from 0 minutes to 120 minutes after consuming the test drink (timepoints 0,5,10,15,20,25,30,35,40,45,50,55,60,70,80,90,100,110,and 120 minutes)

Study Arms (1)

Healthy adults

Healthy male and female participants

Diagnostic Test: Oral glucose tolerance test

Interventions

Oral glucose tolerance test DIAGNOSTIC_TEST

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

Healthy adults

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy male and female adults

You may qualify if:

• Healthy (health status will be confirmed at screening).
• Able to fully comprehend the informed consent process and give informed consent.
• BMI \<30 kg/m2

You may not qualify if:

• Known contraindication to MRI scanning (for example, pacemaker/implanted defibrillator, aneurysm clips, implanted programmable device, intra-ocular metallic fragment, claustrophobia)
• Major psychiatric, cognitive or mood disorder.
• Any other significant chronic medical conditions, including diabetes (type 1 and 2), asthma and epilepsy.
• Any acute major illness or surgery within one year prior to participation.
• Glucose intolerance (as assessed by a finger-prick test at screening).
• Having taken part in a research study in the last 3 months involving invasive procedures, ionising radiation or an inconvenience allowance.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Sir Peter Mansfield Imaging Centre

Nottingham, Notts, NG72UH, United Kingdom

Location

MeSH Terms

Interventions

Glucose Tolerance Test

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Officials

• Luca Marciani, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 13, 2023
• Study Start: October 1, 2022
• Primary Completion: March 28, 2023
• Study Completion: March 28, 2023
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)