Clinical trial NCT01919021: 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
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
Diabetic Gastroparesis
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2013-08-08
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

1. Be an adult patient above 18 years old
2. Have a body mass index of \>18 and \<30kg.m2 and not exceed a waist circumference of 99cm at 5cm above ileal crest
3. Be able to give voluntary informed consent and from whom written consent to participate has been obtained.
4. Be able to understand the study, willing to co-operate with the study procedures and able to attend all study assessments.
5. Be willing to abstain from alcohol for 24 hours before and during the imaging appointment.
6. Be willing to fast from midnight prior to the screening and imaging appointment
7. 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)
8. Be able to swallow a solid agar bead between 7.5 and 11.5 mm in diameter
9. Be willing to consent to their General Practitioner (GP) being informed of their participation.

Exclusion Criteria:

1. Have a history of gastrointestinal disease or surgery (other than appendicitis or hysterectomy)
2. Have ongoing disease requiring active management (including impaired renal clearance GFR \<50 mL/min/1.73 m2)
3. Have a documented history of alcohol or drug abuse
4. Fail to satisfy the investigator's assessment of fitness to participate based on a survey of inclusion and exclusion criteria
5. Have consumed alcohol within 24 hours of start of study
6. 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)
7. Take any medication which may affect oesophageal or gastric motility for a minimum 7 days
8. Have had previous history of gastric surgery
9. Have active upper gastrointestinal diseases
10. Have an active Eating Disorder
11. Have an allergy to milk protein (milk based, lactose free test meal)
12. Be a vegan
13. Be pregnant or breastfeeding
14. Have any contraindication to MRI scanning according to local guidelines

Primary outcomes:
measure: Maximum volume ingested at nutrient drink test (ml)
timeFrame: Study Day
measure: Gastric emptying rate (ml/min) for liquids
timeFrame: Study day
measure: Gastric emptying rate (ml/min) for solids
timeFrame: Study Day
measure: Time taken for 50% gastric emptying (T50, minutes) for liquids
timeFrame: Study day-After 50% of contents of stomach has emptied
measure: Time take for 50% gastric emptying (T50, minutes) solids
timeFrame: Study day-after 50% of contents of stomach has emptied
Secondary outcomes:
measure: Sensation at 200ml, 400ml and at completion of nutrient drink test (fullness, bloating, nausea, heartburn, epigastric pain)
timeFrame: Study day
measure: Glycaemic response at 15 minutes and 30 minutes post 400ml milkshake
timeFrame: study day
measure: Gastric volume at 200ml nutrient ingestion
timeFrame: Study day
measure: Gastric volume at 400ml nutrient ingestion
timeFrame: study day
measure: Gastric contractile wave contractile frequency
timeFrame: study day
measure: Oro-caecal Transit time
timeFrame: study day
measure: Sensation threshold volume for fullness, bloating, nausea, heartburn and epigastric pain
timeFrame: study day
measure: Sensation at 200ml and 400ml ingestion of test meal (fullness, bloating, nausea, heartburn, epigastric pain)
timeFrame: study day
measure: GI Hormone Assessment
timeFrame: Study day
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: National Institute of Health Research Biomedical Research Unit, Nottingham Digestve Diseases Centre, University of Nottingham,
Study officials:
affiliation: University of Nottingham
name: Mark Fox, BMBS, MD
role: PRINCIPAL_INVESTIGATOR
References: