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

Status Completed

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.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01919021
Study type	Interventional
Source	Nottingham University Hospitals NHS Trust
Contact
Status	Completed
Phase	N/A
Start date	April 2011
Completion date	April 2014

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms