Gastrointestinal DysfunctionMRIValNCT05765123
Gastric Emptying Validation Pilot Study (MRI Val)
An observational study of Gastrointestinal Dysfunction, run by University of Nottingham at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Dysfunction
- What is being tested?
- Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 28 Mar 2023
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy male and female adults
Who may be able to join
- Healthy (health status will be confirmed at screening).
- Able to fully comprehend the informed consent process and give informed consent.
- BMI <30 kg/m2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sir Peter Mansfield Imaging Centre
Nottingham, Notts, NG72UH
About this study
Official title: A Pilot, Validation Study to Assess Sequential MRI Scanning on a 0.5 Tesla Upright Scanner as a Method to Determine Gastric Emptying Rate
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.
Read the detailed description
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.
- Conditions
- Gastrointestinal Dysfunction
- Being tested
- Oral glucose tolerance test
- Keywords
- gastric emptying, Magnetic resonance imaging, '13-C acetate' breath test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testDiagnostic test
A drink containing 75g of glucose together with 150mg carbon-13 sodium acetate in 300ml water
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy male and female participants Receives: Diagnostic Test: Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI gastric emptying rate (T50)
Gastric emptying rate (ml/min) derived from the decrease in volume of gastric contents
Measured: 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
Measured: assessment made over 120 minutes (timepoints from 0 minutes to 120 minutes after consuming test drink)
Secondary outcomes (2)
Volume of gastric contents
Volume of gastric contents determined from MRI images (ml)
Measured: 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
carbon 13 labelled CO2 content in the breath measured using mass spectrometry
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Oct 2022
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Marciani, University of Nottingham
- Investigators
- Luca Marciani, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765123
- Sponsor's protocol ID
- 40-0822
- Acronym
- MRIVal
- Status last verified
- Jul 2023
- First submitted
- 16 Feb 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: anonymised data only shared where specific consent for data use in further studies has been given by the participants
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Validation Study to Assess Sequential MRI Scanning on a 0.5 Tesla Upright Scanner as a Method to Determine Gastric Emptying Rate
- ClinicalTrials.gov ID
- NCT05765123
- Acronym / sponsor ID
- MRIVal / 40-0822
- Conditions
- Gastrointestinal Dysfunction
- Keywords
- gastric emptying, Magnetic resonance imaging, '13-C acetate' breath test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Diagnostic Test: Oral glucose tolerance testHealthy male and female participants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy male and female adults
Key inclusion criteria (3 listed)
- Healthy (health status will be confirmed at screening).
- Able to fully comprehend the informed consent process and give informed consent.
- BMI <30 kg/m2
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose tolerance testA drink containing 75g of glucose together with 150mg carbon-13 sodium acetate in 300ml water | Diagnostic test | Healthy adults |
Primary outcome
MRI gastric emptying rate (T50)
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
13-Carbon labelled Sodium Acetate Breath test gastric emptying rate (T50)
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
2 secondary outcomes
Volume of gastric contents
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-enrichment of breath CO2
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No. anonymised data only shared where specific consent for data use in further studies has been given by the participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Marciani, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Dysfunction, run by University of Nottingham at 1 site in United Kingdom.
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 3 inclusion and 6 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 13 Jul 2023. 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 United Kingdom. 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?
MRI gastric emptying rate (T50) (time frame: assessment made over 120 minutes (timepoints from 0 minutes to 120 minutes after consuming test drink)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2023.