Status:
COMPLETED
Assessment of Gastro-Intestinal Function to a Mixed Meal by Non-invasive Imaging
Lead Sponsor:
Nottingham University Hospitals NHS Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Functional Dyspepsia
Diabetic Gastroparesis
Eligibility:
All Genders
18-80 years
Phase:
NA
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 f...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- Fail to satisfy the investigator's assessment of fitness to participate based on a survey of inclusion and exclusion criteria
- 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
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01919021
Start Date
April 1 2011
End Date
April 1 2014
Last Update
April 9 2014
Active Locations (1)
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1
National Institute of Health Research Biomedical Research Unit, Nottingham Digestve Diseases Centre, University of Nottingham,
Nottingham, United Kingdom, NG7 2YH