Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

8. april 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

72

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Det Forenede Kongerige
      • Nottingham, Det Forenede Kongerige, NG7 2YH
        • National Institute of Health Research Biomedical Research Unit, Nottingham Digestve Diseases Centre, University of Nottingham,

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum volume ingested at nutrient drink test (ml)
Tidsramme: Study Day
Maximum of milkshake ingested at maximum satiety
Study Day
Gastric emptying rate (ml/min) for liquids
Tidsramme: Study day
gastric emptying rate measured by non-invasive imaging
Study day
Gastric emptying rate (ml/min) for solids
Tidsramme: Study Day
Gastric emptying rate measured by non-invasive imaging
Study Day
Time taken for 50% gastric emptying (T50, minutes) for liquids
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sensation at 200ml, 400ml and at completion of nutrient drink test (fullness, bloating, nausea, heartburn, epigastric pain)
Tidsramme: 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
Tidsramme: study day
Blood glucose (mmol/l)
study day
Gastric volume at 200ml nutrient ingestion
Tidsramme: Study day
Measurement of gastric volume (ml) on MRI and gamma scintigraphy
Study day
Gastric volume at 400ml nutrient ingestion
Tidsramme: study day
measurement of gastric volume (ml) on MRI and gamma scintography
study day
Gastric contractile wave contractile frequency
Tidsramme: study day
contractile frequency within stomach
study day
Oro-caecal Transit time
Tidsramme: study day
Time taken for 50% gastric contents to enter caecum
study day
Sensation threshold volume for fullness, bloating, nausea, heartburn and epigastric pain
Tidsramme: 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)
Tidsramme: study day
Visual analogue score for each sensation (score up to 100 points)
study day
GI Hormone Assessment
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nottingham University Hospitals NHS Trust

Samarbejdspartnere

National Institute for Health Research, United Kingdom

Efterforskere

  • Ledende efterforsker: Mark Fox, BMBS, MD, University of Nottingham

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2011

Primær færdiggørelse (Faktiske)

1. april 2014

Studieafslutning (Faktiske)

1. april 2014

Datoer for studieregistrering

Først indsendt

10. juli 2013

Først indsendt, der opfyldte QC-kriterier

5. august 2013

Først opslået (Skøn)

8. august 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. april 2014

Sidst verificeret

1. april 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11GA006

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Magnetic Resonance Imaging MRI

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Oman

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner