| Registry | NCT03176927 |
|---|---|
| Status | Completed |
| Phase | Early Phase 1 |
| Study type | Interventional; non randomized, single group, masking: none, basic science |
| Enrollment | 22 (Actual) |
| Sponsor | Vanderbilt University Medical Center (Other); collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Conditions | Diabetics Without Symptoms of Gastroparesis, Diabetic Gastroparesis, Idiopathic Gastroparesis, Total or Partial Gastrectomy, Chronic Nausea, Functional Dyspepsia |
| Interventions | magnetogastrogram (Diagnostic test) |
| Dates | start 2012-12-28, primary completion 2021-05-19, completion 2021-05-19, first posted 2017-06-06, last updated 2026-04-22 |
| Locations | 1 site in United States |
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All trials for Diabetics Without Symptoms of Gastroparesis All trials for Diabetic Gastroparesis All trials of magnetogastrogram
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.
5/23/25. Study record updated to reflect Early Phase 1/Phase 0 trial. The main aim of the study was to evaluate MGG as a device for classification of functional gastric disorders.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Gastroparesis | Experimental | Diagnostic Test: magnetogastrogram | magnetogastrogram Diabetes with and without gastroparesis ; Idiopathic gastroparesis |
| Gastrectomy | Experimental | Diagnostic Test: magnetogastrogram | magnetogastrogram Total or partial gastrectomy group |
| Functional dyspepsia | Experimental | Diagnostic Test: magnetogastrogram | magnetogastrogram Children with functional dyspepsia |
| Chronic nausea | Experimental | Diagnostic Test: magnetogastrogram | magnetogastrogram Children with chronic nausea |
| Control participants | Experimental | Diagnostic Test: magnetogastrogram | magnetogastrogram Group without any gastrointestinal diseases. |
Sex: All, ages: 12 Years to 80 Years, accepts healthy volunteers
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Vanderbilt University Medical Center | Nashville, Tennessee | United States |
NIH grants: R01DK058697