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Completed

NCT Number: NCT01919021

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

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.

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Key information

Conditions

Functional Dyspepsia Diabetic Gastroparesis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Health Research Biomedical Research Unit, Nottingham Digestve Diseases Centre, University of Nottingham,

Nottingham, NG7 2YH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging MRI

Other

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

Other

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 function

Procedure

Primary outcomes

  1. Maximum volume ingested at nutrient drink test (ml)

    Time frame: Study Day

    Maximum of milkshake ingested at maximum satiety

  2. Gastric emptying rate (ml/min) for liquids

    Time frame: Study day

    gastric emptying rate measured by non-invasive imaging

  3. Gastric emptying rate (ml/min) for solids

    Time frame: Study Day

    Gastric emptying rate measured by non-invasive imaging

  4. 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

  5. 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

Secondary outcomes

  1. Sensation at 200ml, 400ml and at completion of nutrient drink test (fullness, bloating, nausea, heartburn, epigastric pain)

    Time frame: Study day

    Visual analogue score for each sensation (score up to 100 points)

  2. Glycaemic response at 15 minutes and 30 minutes post 400ml milkshake

    Time frame: study day

    Blood glucose (mmol/l)

  3. Gastric volume at 200ml nutrient ingestion

    Time frame: Study day

    Measurement of gastric volume (ml) on MRI and gamma scintigraphy

  4. Gastric volume at 400ml nutrient ingestion

    Time frame: study day

    measurement of gastric volume (ml) on MRI and gamma scintography

  5. Gastric contractile wave contractile frequency

    Time frame: study day

    contractile frequency within stomach

  6. Oro-caecal Transit time

    Time frame: study day

    Time taken for 50% gastric contents to enter caecum

  7. Sensation threshold volume for fullness, bloating, nausea, heartburn and epigastric pain

    Time frame: study day

    Gastric volume recorded at time of maximum symptom scores

  8. Sensation at 200ml and 400ml ingestion of test meal (fullness, bloating, nausea, heartburn, epigastric pain)

    Time frame: study day

    Visual analogue score for each sensation (score up to 100 points)

  9. GI Hormone Assessment

    Time frame: Study day

    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.

Sponsors and collaborators

Lead sponsor

Nottingham University Hospitals NHS Trust

Other

Collaborators

  • National Institute for Health Research, United Kingdom

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 8, 2013
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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