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

Primary Purpose

Dyspepsia, Healthy Volunteers

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dyspepsia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic

Outcomes

Primary Outcome Measures

Gastric Volume (fasting and postprandial)
Antral Contractility

Secondary Outcome Measures

Full Information

First Posted
January 10, 2006
Last Updated
April 27, 2009
Sponsor
Mayo Clinic
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00275743
Brief Title
Use of MRI for Assessing Stomach Relaxation in Response to a Meal
Official Title
Dynamic MRI - A Novel Approach for Measuring Gastric Accommodation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia, Healthy Volunteers

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
MRI
Primary Outcome Measure Information:
Title
Gastric Volume (fasting and postprandial)
Title
Antral Contractility

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adil E. Bharucha, M.B.B.S., M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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