Assessment of Gastro-Intestinal Function to a Mixed Meal by Non-invasive Imaging

Functional Dyspepsia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919021
• Other study ID #: 11GA006
• Status: Completed
• Phase: N/A
• First received: July 10, 2013
• Last updated: April 8, 2014
• Start date: April 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Nottingham University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: England: National Research Ethics Service
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Functional Dyspepsia
• Gastroparesis

Intervention

Other:
• Magnetic Resonance Imaging MRI
400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier.
• Gamma Scintigraphy
400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier.

Procedure:
• Assessment of Gastric motor and sensory function

Locations

Country	Name	City	State
United Kingdom	National Institute of Health Research Biomedical Research Unit, Nottingham Digestve Diseases Centre, University of Nottingham,	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum volume ingested at nutrient drink test (ml)	Maximum of milkshake ingested at maximum satiety	Study Day	No
Primary	Gastric emptying rate (ml/min) for liquids	gastric emptying rate measured by non-invasive imaging	Study day	No
Primary	Gastric emptying rate (ml/min) for solids	Gastric emptying rate measured by non-invasive imaging	Study Day	No
Primary	Time taken for 50% gastric emptying (T50, minutes) for liquids	time taken for 50% of gastric contents to leave the stomach	Study day-After 50% of contents of stomach has emptied	No
Primary	Time take for 50% gastric emptying (T50, minutes) solids	Time taken for 50% of gastric contents to leave the stomach	Study day-after 50% of contents of stomach has emptied	No
Secondary	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)	Study day	No
Secondary	Glycaemic response at 15 minutes and 30 minutes post 400ml milkshake	Blood glucose (mmol/l)	study day	No
Secondary	Gastric volume at 200ml nutrient ingestion	Measurement of gastric volume (ml) on MRI and gamma scintigraphy	Study day	No
Secondary	Gastric volume at 400ml nutrient ingestion	measurement of gastric volume (ml) on MRI and gamma scintography	study day	No
Secondary	Gastric contractile wave contractile frequency	contractile frequency within stomach	study day	No
Secondary	Oro-caecal Transit time	Time taken for 50% gastric contents to enter caecum	study day	No
Secondary	Sensation threshold volume for fullness, bloating, nausea, heartburn and epigastric pain	Gastric volume recorded at time of maximum symptom scores	study day	No
Secondary	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)	study day	No
Secondary	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.	Study day	No