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Use of MRI for Assessing Stomach Relaxation in Response to a Meal

Dynamic MRI - A Novel Approach for Measuring Gastric Accommodation

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00275743
Enrollment
50
Registered
2006-01-12
Start date
2005-10-31
Completion date
2008-12-31
Last updated
2009-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia, Healthy Volunteers

Brief summary

This study is being done to test new way of measuring the relaxation of the stomach after a meal (called gastric accommodation) by using a MRI scan. This new test will be compared with the standard test of measuring stomach relaxation that uses radioactive tracers. These tests will be compared in healthy volunteers and people with upper abdominal symptoms (known as dyspepsia).

Interventions

PROCEDUREMRI

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

for Dyspeptic patients (30 required) * One or more of eight postprandial dyspeptic symptoms i.e. fullness, bloating, epigastric discomfort, early satiety, nausea, vomiting, belching, pain for a minimum of 3 months, OR * Patients fulfilling the ROME-II criteria for functional dyspepsia, * AND no symptom improvement after standard dose PPI treatment, * AND normal upper gastrointestinal endoscopy within six months prior to the study Inclusion Criteria for Healthy Controls (20 required) • Absence of current abdominal symptoms or depression

Exclusion criteria

for all Participants * Known structural upper GI disorder (e.g. peptic ulcer disease, esophagitis, malignancy); * Abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, tubal ligation, or inguinal hernia repair; * Medications that may alter gastrointestinal motility, e.g., serotoninergic agents, alpha adrenergic agonists, calcium channel or beta blockers; stable dose of thyroxine will be permitted; * Pregnant or breast-feeding females; * Known claustrophobia; * Any metal objects in the body (e.g. metal implants, pacemaker, AICD)

Design outcomes

Primary

MeasureTime frame
Gastric Volume (fasting and postprandial)
Antral Contractility

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026