Biomagnetic Characterization of Gastric Dysrhythmias III

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03176927

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

150

Enrollment

Location

Arms

128

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

There is a tremendous clinical need for a noninvasive technique that can assess gastric electrical activity and would be repeatable without any exposure to radiation. Investigators developed a new technique allowing to use noninvasive methods to assess bioelectrical activity in the gastrointestinal system. This has enabled to characterize the normal and pathologic physiology of the stomach through the use of noninvasive magnetogastrogram (MGG) records. Primary hypothesis for this proposal is that analysis of gastric slow wave uncoupling and propagation in multichannel MGG discriminates between normal and pathological gastric electrical activity. Eventually, investigators envision this research leading to new insights for gastrointestinal conditions such as gastroparesis, functional dyspepsia and chronic idiopathic nausea that would inform clinical management of these debilitating diseases.

Condition or Disease	Intervention/Treatment	Phase
Diabetics Without Symptoms of Gastroparesis Diabetic Gastroparesis Idiopathic Gastroparesis Total or Partial Gastrectomy Chronic Nausea Functional Dyspepsia	Diagnostic Test: magnetogastrogram	N/A

Detailed Description

Studies have demonstrated that the magnetogastrogram (MGG) records the same gastric slow wave activity that detect with serosal and mucosal electrodes. The upgraded magnetometer will improve the spatial resolution resulting in increased sensitivity for detecting and characterizing both abnormal frequency dynamics and abnormal spatiotemporal patterns. The spatiotemporal data collected with multichannel Superconducting QUantum Interference Device (SQUID) biomagnetometer has allowed , for the first time, to characterize propagation of the gastric slow wave noninvasively. In addition to frequency dynamic changes, which are the only reliable parameters from cutaneous electrogastrogram (EGG), and which still do not necessarily correlate well with disease, the MGG reflects normal and abnormal gastric slow wave activity. Furthermore, for the first time, investigators have demonstrated that propagation characteristics determined magnetically distinguish normal subjects from patients with gastroparesis. Also for the first time, investigators have been able to detect the gradient in gastric propagation velocity noninvasively in animal subjects. However, investigators still have unresolved questions about how MGG propagation rhythm and pattern disturbances may specify functional disorders.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Biomagnetic Characterization of Gastric Dysrhythmias III

Study Start Date :

Dec 1, 2012

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gastroparesis magnetogastrogram Diabetes with and without gastroparesis ; Idiopathic gastroparesis	Diagnostic Test: magnetogastrogram
Experimental: Gastrectomy magnetogastrogram Total or partial gastrectomy group	Diagnostic Test: magnetogastrogram
Experimental: Functional dyspepsia magnetogastrogram Children with functional dyspepsia	Diagnostic Test: magnetogastrogram
Experimental: Chronic nausea magnetogastrogram Children with chronic nausea	Diagnostic Test: magnetogastrogram
Experimental: Control participants magnetogastrogram Group without any gastrointestinal diseases.	Diagnostic Test: magnetogastrogram

Outcome Measures

Primary Outcome Measures

Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach [1 day]

Secondary Outcome Measures

Measurement of gastric slow wave propagation velocity in gastroparesis patients [1 day]
Measurement of invasive serosal electromyogram before and after partial/total gastrectomy. [day 1 and day 30]
Measurement of noninvasive magnetogastrogram before and after partial/total gastrectomy. [day 1 and day 30]
Noninvasive measurement of gastric slow wave dysrhythmia in pediatric patients with nausea and functional dyspepsia [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participants between ages 12-80
Diabetic patients with gastroparesis, diabetic patients without gastroparesis and who are willing to have a gastric emptying test if they have not had one in the last 6 months and an IV inserted.
Patients with idiopathic gastroparesis
Total or partial gastrectomy patients
Children (ages 12-17) with functional dyspepsia
Children (ages 12-17) with chronic nausea

Exclusion Criteria:

Those with claustrophobia who cannot lie still under the SQUID for the length of time required.
Normal participants with known intestinal complications
Pregnant females (females who are able to have children will be given a pregnancy test).
Morbid obesity (these patients are presumably unable to lie under the current generation of SQUID devices).
Patients with a history of cardiac arrhythmias, taking anticoagulants, or greater than 80 years of age will be excluded.