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

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

Interventions

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.

OTHER

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

Sponsors & Collaborators

• National Institute for Health Research, United Kingdom

  collaborator OTHER_GOV

• Nottingham University Hospitals NHS Trust

  lead OTHER

Principal Investigators

• Mark Fox, BMBS, MD · University of Nottingham

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2014-04-30

Completion

2014-04-30

Countries

• United Kingdom

Study Locations