Back to resultsAssessment of Gastro-Intestinal Function to a Mixed Meal by Non-invasive Imaging
Primary Purpose
Functional Dyspepsia, Diabetic Gastroparesis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Magnetic Resonance Imaging MRI
Gamma Scintigraphy
Assessment of Gastric motor and sensory function
Sponsored by
About this trial
This is an interventional diagnostic trial for Functional Dyspepsia
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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)
- 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
Sites / Locations
- National Institute of Health Research Biomedical Research Unit, Nottingham Digestve Diseases Centre, University of Nottingham,
Outcomes
Primary Outcome Measures
Maximum volume ingested at nutrient drink test (ml)
Maximum of milkshake ingested at maximum satiety
Gastric emptying rate (ml/min) for liquids
gastric emptying rate measured by non-invasive imaging
Gastric emptying rate (ml/min) for solids
Gastric emptying rate measured by non-invasive imaging
Time taken for 50% gastric emptying (T50, minutes) for liquids
time taken for 50% of gastric contents to leave the stomach
Time take for 50% gastric emptying (T50, minutes) solids
Time taken for 50% of gastric contents to leave the stomach
Secondary Outcome Measures
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)
Glycaemic response at 15 minutes and 30 minutes post 400ml milkshake
Blood glucose (mmol/l)
Gastric volume at 200ml nutrient ingestion
Measurement of gastric volume (ml) on MRI and gamma scintigraphy
Gastric volume at 400ml nutrient ingestion
measurement of gastric volume (ml) on MRI and gamma scintography
Gastric contractile wave contractile frequency
contractile frequency within stomach
Oro-caecal Transit time
Time taken for 50% gastric contents to enter caecum
Sensation threshold volume for fullness, bloating, nausea, heartburn and epigastric pain
Gastric volume recorded at time of maximum symptom scores
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)
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.
Full Information
NCT ID
NCT01919021
First Posted
July 10, 2013
Last Updated
April 8, 2014
Sponsor
Nottingham University Hospitals NHS Trust
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT01919021
Brief Title
Assessment of Gastro-Intestinal Function to a Mixed Meal by Non-invasive Imaging
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Diabetic Gastroparesis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging MRI
Intervention Description
400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier.
Intervention Type
Other
Intervention Name(s)
Gamma Scintigraphy
Intervention Description
400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier.
Intervention Type
Procedure
Intervention Name(s)
Assessment of Gastric motor and sensory function
Primary Outcome Measure Information:
Title
Maximum volume ingested at nutrient drink test (ml)
Description
Maximum of milkshake ingested at maximum satiety
Time Frame
Study Day
Title
Gastric emptying rate (ml/min) for liquids
Description
gastric emptying rate measured by non-invasive imaging
Time Frame
Study day
Title
Gastric emptying rate (ml/min) for solids
Description
Gastric emptying rate measured by non-invasive imaging
Time Frame
Study Day
Title
Time taken for 50% gastric emptying (T50, minutes) for liquids
Description
time taken for 50% of gastric contents to leave the stomach
Time Frame
Study day-After 50% of contents of stomach has emptied
Title
Time take for 50% gastric emptying (T50, minutes) solids
Description
Time taken for 50% of gastric contents to leave the stomach
Time Frame
Study day-after 50% of contents of stomach has emptied
Secondary Outcome Measure Information:
Title
Sensation at 200ml, 400ml and at completion of nutrient drink test (fullness, bloating, nausea, heartburn, epigastric pain)
Description
Visual analogue score for each sensation (score up to 100 points)
Time Frame
Study day
Title
Glycaemic response at 15 minutes and 30 minutes post 400ml milkshake
Description
Blood glucose (mmol/l)
Time Frame
study day
Title
Gastric volume at 200ml nutrient ingestion
Description
Measurement of gastric volume (ml) on MRI and gamma scintigraphy
Time Frame
Study day
Title
Gastric volume at 400ml nutrient ingestion
Description
measurement of gastric volume (ml) on MRI and gamma scintography
Time Frame
study day
Title
Gastric contractile wave contractile frequency
Description
contractile frequency within stomach
Time Frame
study day
Title
Oro-caecal Transit time
Description
Time taken for 50% gastric contents to enter caecum
Time Frame
study day
Title
Sensation threshold volume for fullness, bloating, nausea, heartburn and epigastric pain
Description
Gastric volume recorded at time of maximum symptom scores
Time Frame
study day
Title
Sensation at 200ml and 400ml ingestion of test meal (fullness, bloating, nausea, heartburn, epigastric pain)
Description
Visual analogue score for each sensation (score up to 100 points)
Time Frame
study day
Title
GI Hormone Assessment
Description
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.
Time Frame
Study day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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.
Exclusion Criteria:
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Fox, BMBS, MD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Health Research Biomedical Research Unit, Nottingham Digestve Diseases Centre, University of Nottingham,
City
Nottingham
ZIP/Postal Code
NG7 2YH
Country
United Kingdom
12. IPD Sharing Statement
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Assessment of Gastro-Intestinal Function to a Mixed Meal by Non-invasive Imaging
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