Functional DyspepsiaNCT01919021
Assessment of Gastro-Intestinal Function to a Mixed Meal by Non-invasive Imaging
A study testing Magnetic Resonance Imaging MRI, Gamma Scintigraphy and Assessment of Gastric motor and sensory function in people with Functional Dyspepsia and Diabetic Gastroparesis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Dyspeptic symptoms, such as pain after eating, bloating and nausea all have major impact on quality of life and health care costs. When no structural cause is identified, patients are diagnosed with functional dyspepsia. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Dyspepsia, Diabetic Gastroparesis
- What is being tested?
- Magnetic Resonance Imaging MRI, Gamma Scintigraphy and Assessment of Gastric motor and sensory function
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Apr 2014
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be an adult patient above 18 years old
- Have a body mass index of >18 and <30kg.m2 and not exceed a waist circumference of 99cm at 5cm above ileal crest
- Be able to give voluntary informed consent and from whom written consent to participate has been obtained.
- Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments.
- Be willing to abstain from alcohol for 24 hours before and during the imaging appointment.
- Be willing to fast from midnight prior to the screening and imaging appointment
Show all 9Show fewer
- Be able to ingest at least 400ml nutrient liquid (0.75kcal/ml at 40ml/min) during a Nutrient Drinking Test without experiencing more than moderate dyspeptic symptoms (no such restriction for patients with dyspeptic symptoms)
- Be able to swallow a solid agar bead between 7.5 and 11.5 mm in diameter
- Be willing to consent to their General Practitioner (GP) being informed of their participation.
Who cannot join
- Have a history of gastrointestinal disease or surgery (other than appendicitis or hysterectomy)
- Have ongoing disease requiring active management (including impaired renal clearance GFR <50 mL/min/1.73 m2)
- Have a documented history of alcohol or drug abuse
- Fail to satisfy the investigator's assessment of fitness to participate based on a survey of inclusion and exclusion criteria
- Have consumed alcohol within 24 hours of start of study
- Have participated in a similar study involving the use of radioisotopes in the previous 3 months such that participating in the current study would exceed the recommended yearly exposure limit (5mSv)
Show all 14Show fewer
- Take any medication which may affect oesophageal or gastric motility for a minimum 7 days
- Have had previous history of gastric surgery
- Have active upper gastrointestinal diseases
- Have an active Eating Disorder
- Have an allergy to milk protein (milk based, lactose free test meal)
- Be a vegan
- Be pregnant or breastfeeding
- Have any contraindication to MRI scanning according to local guidelines
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Institute of Health Research Biomedical Research Unit, Nottingham Digestve Diseases Centre, University of Nottingham,
Nottingham, NG7 2YH
About this study
Official title: Pilot Study: Assessment of Gastric Motor and Sensory Function to a Mixed Liquid and Solid Test Meal by Gamma Scintigraphy, Magnetic Resonance Imaging and a Nutrient Drink Test in Health and Patients With Disorders of Gastric Function
Dyspeptic symptoms, such as pain after eating, bloating and nausea all have major impact on quality of life and health care costs. When no structural cause is identified, patients are diagnosed with functional dyspepsia. This trial aims to identify objective abnormalities of stomach function that explain patient's symptoms and establish diagnosis. Another group are diabetic patients who can often develop similar symptoms, labelled as diabetic gastroparesis. In some cases this is associated with delayed gastric emptying but not all.
24 patients with functional dyspepsia will be studied and 24 healthy controls (to establish normal ranges) and 24 diabetic patients with symptoms of functional dyspepsia.
Read more
The utility of 3 different non-invasive investigations will be assessed. At screening the nutrient drink test (NDT) asks the patient to drink 40ml of milkshake (0.75kcal/ml) every minute and score symptoms every 5 minutes. The patient continues until they reach the maximum tolerated volume.
Participants will then be randomized to undergo non-invasive imaging on two separate test days by magnetic resonance imaging (MRI) and gastric scintigraphy MRI will be completed with the patient ingesting 400ml of milkshake (identical to NDT) and 12 agar beads (no additional calories) of known breaking strength. The emptying of the stomach will be visualised with the MRI alongside symptom recording.
Gamma scintigraphy will ingest the same meal as for the MRI scan but radioactive labelling will allow the rate of liquid and solid meal emptying to be visualised alongside symptom recording.
Additionally, blood sugars will be recorded before nutrient drink test and at 15 and 30 minutes following ingestion of 400ml of milkshake and 12 agar beads.
Data will be analyzed to assess the association of objective abnormalities of gastric function and patient symptoms. Additionally the results of non-invasive imaging by MRI and GS will be compared to assess the optimal measurement of gastric function and emptying in this clinical scenario.
- Conditions
- Functional Dyspepsia, Diabetic Gastroparesis
- Being tested
- Magnetic Resonance Imaging MRI, Gamma Scintigraphy, Assessment of Gastric motor and sensory function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging MRIOther
400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier.
Gamma ScintigraphyOther
400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier.
Assessment of Gastric motor and sensory functionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum volume ingested at nutrient drink test (ml)
Maximum of milkshake ingested at maximum satiety
Measured: Study Day
Gastric emptying rate (ml/min) for liquids
gastric emptying rate measured by non-invasive imaging
Measured: Study day
Gastric emptying rate (ml/min) for solids
Gastric emptying rate measured by non-invasive imaging
Measured: Study Day
Time taken for 50% gastric emptying (T50, minutes) for liquids
time taken for 50% of gastric contents to leave the stomach
Measured: Study day-After 50% of contents of stomach has emptied
Time take for 50% gastric emptying (T50, minutes) solids
Time taken for 50% of gastric contents to leave the stomach
Measured: Study day-after 50% of contents of stomach has emptied
Secondary outcomes (9)
Sensation at 200ml, 400ml and at completion of nutrient drink test (fullness, bloating, nausea, heartburn, epigastric pain)
Visual analogue score for each sensation (score up to 100 points)
Measured: Study day
Glycaemic response at 15 minutes and 30 minutes post 400ml milkshake
Blood glucose (mmol/l)
Measured: study day
Gastric volume at 200ml nutrient ingestion
Measurement of gastric volume (ml) on MRI and gamma scintigraphy
Measured: Study day
Gastric volume at 400ml nutrient ingestion
measurement of gastric volume (ml) on MRI and gamma scintography
Measured: study day
Gastric contractile wave contractile frequency
contractile frequency within stomach
Measured: study day
Oro-caecal Transit time
Time taken for 50% gastric contents to enter caecum
Measured: study day
Sensation threshold volume for fullness, bloating, nausea, heartburn and epigastric pain
Gastric volume recorded at time of maximum symptom scores
Measured: study day
Sensation at 200ml and 400ml ingestion of test meal (fullness, bloating, nausea, heartburn, epigastric pain)
Visual analogue score for each sensation (score up to 100 points)
Measured: study day
GI Hormone Assessment
5 ml of blood will be taken at time 0, 30, 60 and 120 min. GI peptide hormones will then be analysed from the samples.
Measured: Study day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startApr 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Mark Fox, BMBS, MD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919021
- Sponsor's protocol ID
- 11GA006
- Status last verified
- Apr 2014
- First submitted
- 10 Jul 2013
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Assessment of Gastric Motor and Sensory Function to a Mixed Liquid and Solid Test Meal by Gamma Scintigraphy, Magnetic Resonance Imaging and a Nutrient Drink Test in Health and Patients With Disorders of Gastric Function
- ClinicalTrials.gov ID
- NCT01919021
- Acronym / sponsor ID
- 11GA006
- Conditions
- Functional Dyspepsia, Diabetic Gastroparesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Apr 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 8 Aug 2013 (estimated)
- 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.
Dyspeptic symptoms, such as pain after eating, bloating and nausea all have major impact on quality of life and health care costs. When no structural cause is identified, patients are diagnosed with functional dyspepsia. This trial aims to identify objective abnormalities of stomach function that explain patient's symptoms and establish diagnosis. Another group are diabetic patients who can often develop similar symptoms, labelled as diabetic gastroparesis. In some cases this is associated with delayed gastric emptying but not all.
24 patients with functional dyspepsia will be studied and 24 healthy controls (to establish normal ranges) and 24 diabetic patients with symptoms of functional dyspepsia.
The utility of 3 different non-invasive investigations will be assessed. At screening the nutrient drink test (NDT) asks the patient to drink 40ml of milkshake (0.75kcal/ml) every minute and score symptoms every 5 minutes. The patient continues until they reach the maximum tolerated volume.
Participants will then be randomized to undergo non-invasive imaging on two separate test days by magnetic resonance imaging (MRI) and gastric scintigraphy MRI will be completed with the patient ingesting 400ml of milkshake (identical to NDT) and 12 agar beads (no additional calories) of known breaking strength. The emptying of the stomach will be visualised with the MRI alongside symptom recording.
Gamma scintigraphy will ingest the same meal as for the MRI scan but radioactive labelling will allow the rate of liquid and solid meal emptying to be visualised alongside symptom recording.
Additionally, blood sugars will be recorded before nutrient drink test and at 15 and 30 minutes following ingestion of 400ml of milkshake and 12 agar beads.
Data will be analyzed to assess the association of objective abnormalities of gastric function and patient symptoms. Additionally the results of non-invasive imaging by MRI and GS will be compared to assess the optimal measurement of gastric function and emptying in this clinical scenario.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be an adult patient above 18 years old
- Have a body mass index of >18 and <30kg.m2 and not exceed a waist circumference of 99cm at 5cm above ileal crest
- Be able to give voluntary informed consent and from whom written consent to participate has been obtained.
- Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments.
- Be willing to abstain from alcohol for 24 hours before and during the imaging appointment.
Key exclusion criteria (14 listed)
- Have a history of gastrointestinal disease or surgery (other than appendicitis or hysterectomy)
- Have ongoing disease requiring active management (including impaired renal clearance GFR <50 mL/min/1.73 m2)
- Have a documented history of alcohol or drug abuse
- Fail to satisfy the investigator's assessment of fitness to participate based on a survey of inclusion and exclusion criteria
- Have consumed alcohol within 24 hours of start of study
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 |
|---|---|---|
| Magnetic Resonance Imaging MRI400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier. | Other | – |
| Gamma Scintigraphy400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier. | Other | – |
| Assessment of Gastric motor and sensory function | Procedure or surgery | – |
Primary outcome
Maximum volume ingested at nutrient drink test (ml)
Time frame: Study Day
Maximum of milkshake ingested at maximum satiety
Gastric emptying rate (ml/min) for liquids
Time frame: Study day
gastric emptying rate measured by non-invasive imaging
Gastric emptying rate (ml/min) for solids
Time frame: Study Day
Gastric emptying rate measured by non-invasive imaging
Time taken for 50% gastric emptying (T50, minutes) for liquids
Time frame: Study day-After 50% of contents of stomach has emptied
time taken for 50% of gastric contents to leave the stomach
Time take for 50% gastric emptying (T50, minutes) solids
Time frame: Study day-after 50% of contents of stomach has emptied
Time taken for 50% of gastric contents to leave the stomach
9 secondary outcomes
Sensation at 200ml, 400ml and at completion of nutrient drink test (fullness, bloating, nausea, heartburn, epigastric pain)
Time frame: Study day
Glycaemic response at 15 minutes and 30 minutes post 400ml milkshake
Time frame: study day
Gastric volume at 200ml nutrient ingestion
Time frame: Study day
Gastric volume at 400ml nutrient ingestion
Time frame: study day
Gastric contractile wave contractile frequency
Time frame: study day
Oro-caecal Transit time
Time frame: study day
Sensation threshold volume for fullness, bloating, nausea, heartburn and epigastric pain
Time frame: study day
Sensation at 200ml and 400ml ingestion of test meal (fullness, bloating, nausea, heartburn, epigastric pain)
Time frame: study day
GI Hormone Assessment
Time frame: Study day
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 9 Apr 2014.
Related trials for Functional Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
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.
Mark Fox, BMBS, MD 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?
A study testing Magnetic Resonance Imaging MRI, Gamma Scintigraphy and Assessment of Gastric motor and sensory function in people with Functional Dyspepsia and Diabetic Gastroparesis, run by Nottingham University Hospitals NHS Trust 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 9 inclusion and 14 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 9 Apr 2014. 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?
Maximum volume ingested at nutrient drink test (ml) (time frame: Study Day). The study lists 5 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 9 Apr 2014.