Sir Peter Mansfield Imaging Centre
Nottingham, Notts, NG72UH, United Kingdom
NCT Number: NCT05765123
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.
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Notify Me18 year–60 year
All sexes
Observational
Nottingham, Notts, NG72UH, United Kingdom
The rate at which food empties from the stomach is a key assessment made in appetite and metabolic research, as well as studies investigating gastrointestinal function in health and disease. This assessment can be achieved by measuring the volume of the stomach contents at timepoints after eating using magnetic resonance imaging (MRI) and calculating the gastric emptying rate from the decrease in volume which occurs over time. However, these measures are traditionally made when the individual is lying supine within the bore of the MRI machine and this postural position may impact the rate that food empties from the stomach. A low-field 0.5 Tesla 'upright' MRI scanner could address the problem of measuring gastric emptying rate when supine. However, the resolution of the images obtained are poorer than those obtained at higher field strengths (e.g. at 3 Tesla). The primary aim of this study is to compare gastric emptying kinetics assessed by sequential MR imaging of the stomach with a standard method which uses a stable isotope tracer (13-Carbon labelled sodium acetate) and breath testing. Twelve healthy, non-obese volunteers (18 to 60 years old) will attend the imaging centre on one occasion in the morning after fasting from midnight and sit within an upright MRI scanner for a period of approximately 140 minutes. Images of their stomach will be taken before and every 5 minutes for 1 hour, and every 10 minutes for the following hour, after consuming a drink containing glucose and 150mg of sodium acetate which contains a heavier (non-radioactive) form of carbon (carbon-13). Before each image is taken, participants will exhale into a 500ml bag to enable a breath sample to be collected. Breath samples will subsequently be analysed for carbon-13 enrichment of expired carbon dioxide (CO2) using mass spectrometry.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A drink containing 75g of glucose together with 150mg carbon-13 sodium acetate in 300ml water
Time frame: assessment made over 120 minutes (timepoints from 0 minutes to 120 minutes after consuming test drink)
Gastric emptying rate (ml/min) derived from the decrease in volume of gastric contents
Time frame: assessment made over 120 minutes (timepoints from 0 minutes to 120 minutes after consuming test drink)
Gastric emptying rate derived (ml/min) from the rate of appearance of carbon 13 labelled CO2 in the breath
Time frame: 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)
Volume of gastric contents determined from MRI images (ml)
Time frame: 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 labelled CO2 content in the breath measured using mass spectrometry
University of Nottingham
Other
A Pilot, Validation Study to Assess Sequential MRI Scanning on a 0.5 Tesla Upright Scanner as a Method to Determine Gastric Emptying Rate
Acronym: MRIVal
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