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

NCT01919021 | Completed

• 1 other identifier: 11GA006
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Dyspepsia; Diabetic Gastroparesis

Outcome Measures

Primary Outcomes (5)

• Maximum volume ingested at nutrient drink test (ml)

  Maximum of milkshake ingested at maximum satiety

  Study Day

• Gastric emptying rate (ml/min) for liquids

  gastric emptying rate measured by non-invasive imaging

  Study day

• Gastric emptying rate (ml/min) for solids

  Gastric emptying rate measured by non-invasive imaging

  Study Day

• 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

• 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

Secondary Outcomes (9)

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

  Study day

• Glycaemic response at 15 minutes and 30 minutes post 400ml milkshake

  study day

• Gastric volume at 200ml nutrient ingestion

  Study day

• Gastric volume at 400ml nutrient ingestion

  study day

• Gastric contractile wave contractile frequency

  study day

Interventions

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

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

Nottingham, NG7 2YH, United Kingdom

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Sensation

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mark Fox, BMBS, MD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: August 8, 2013
• Study Start: April 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 9, 2014

Record last verified: 2014-04

Locations

GB (1)