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

8. April 2014 aktualisiert von: Nottingham University Hospitals NHS Trust

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

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

72

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigtes Königreich
      • Nottingham, Vereinigtes Königreich, NG7 2YH
        • National Institute of Health Research Biomedical Research Unit, Nottingham Digestve Diseases Centre, University of Nottingham,

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Maximum volume ingested at nutrient drink test (ml)
Zeitfenster: Study Day
Maximum of milkshake ingested at maximum satiety
Study Day
Gastric emptying rate (ml/min) for liquids
Zeitfenster: Study day
gastric emptying rate measured by non-invasive imaging
Study day
Gastric emptying rate (ml/min) for solids
Zeitfenster: Study Day
Gastric emptying rate measured by non-invasive imaging
Study Day
Time taken for 50% gastric emptying (T50, minutes) for liquids
Zeitfenster: Study day-After 50% of contents of stomach has emptied
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
Zeitfenster: Study day-after 50% of contents of stomach has emptied
Time taken for 50% of gastric contents to leave the stomach
Study day-after 50% of contents of stomach has emptied

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sensation at 200ml, 400ml and at completion of nutrient drink test (fullness, bloating, nausea, heartburn, epigastric pain)
Zeitfenster: Study day
Visual analogue score for each sensation (score up to 100 points)
Study day
Glycaemic response at 15 minutes and 30 minutes post 400ml milkshake
Zeitfenster: study day
Blood glucose (mmol/l)
study day
Gastric volume at 200ml nutrient ingestion
Zeitfenster: Study day
Measurement of gastric volume (ml) on MRI and gamma scintigraphy
Study day
Gastric volume at 400ml nutrient ingestion
Zeitfenster: study day
measurement of gastric volume (ml) on MRI and gamma scintography
study day
Gastric contractile wave contractile frequency
Zeitfenster: study day
contractile frequency within stomach
study day
Oro-caecal Transit time
Zeitfenster: study day
Time taken for 50% gastric contents to enter caecum
study day
Sensation threshold volume for fullness, bloating, nausea, heartburn and epigastric pain
Zeitfenster: study day
Gastric volume recorded at time of maximum symptom scores
study day
Sensation at 200ml and 400ml ingestion of test meal (fullness, bloating, nausea, heartburn, epigastric pain)
Zeitfenster: study day
Visual analogue score for each sensation (score up to 100 points)
study day
GI Hormone Assessment
Zeitfenster: 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.
Study day

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Nottingham University Hospitals NHS Trust

Mitarbeiter

National Institute for Health Research, United Kingdom

Ermittler

  • Hauptermittler: Mark Fox, BMBS, MD, University of Nottingham

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2011

Primärer Abschluss (Tatsächlich)

1. April 2014

Studienabschluss (Tatsächlich)

1. April 2014

Studienanmeldedaten

Zuerst eingereicht

10. Juli 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. August 2013

Zuerst gepostet (Schätzen)

8. August 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

9. April 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. April 2014

Zuletzt verifiziert

1. April 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 11GA006

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