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Biomagnetic Characterization of Gastric Dysrhythmias III

Primary Purpose

Diabetics Without Symptoms of Gastroparesis, Diabetic Gastroparesis, Idiopathic Gastroparesis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
magnetogastrogram
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetics Without Symptoms of Gastroparesis focused on measuring magnetogastrogram, gastroparesis, electrogastrogram, gastric slow wave

Eligibility Criteria

12 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Gastroparesis

Gastrectomy

Functional dyspepsia

Chronic nausea

Control participants

Arm Description

magnetogastrogram Diabetes with and without gastroparesis ; Idiopathic gastroparesis

magnetogastrogram Total or partial gastrectomy group

magnetogastrogram Children with functional dyspepsia

magnetogastrogram Children with chronic nausea

magnetogastrogram Group without any gastrointestinal diseases.

Outcomes

Primary Outcome Measures

Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach

Secondary Outcome Measures

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

Full Information

First Posted
April 5, 2017
Last Updated
October 12, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03176927
Brief Title
Biomagnetic Characterization of Gastric Dysrhythmias III
Official Title
Biomagnetic Characterization of Gastric Dysrhythmias III
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 2012 (undefined)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetics Without Symptoms of Gastroparesis, Diabetic Gastroparesis, Idiopathic Gastroparesis, Total or Partial Gastrectomy, Chronic Nausea, Functional Dyspepsia
Keywords
magnetogastrogram, gastroparesis, electrogastrogram, gastric slow wave

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gastroparesis
Arm Type
Experimental
Arm Description
magnetogastrogram Diabetes with and without gastroparesis ; Idiopathic gastroparesis
Arm Title
Gastrectomy
Arm Type
Experimental
Arm Description
magnetogastrogram Total or partial gastrectomy group
Arm Title
Functional dyspepsia
Arm Type
Experimental
Arm Description
magnetogastrogram Children with functional dyspepsia
Arm Title
Chronic nausea
Arm Type
Experimental
Arm Description
magnetogastrogram Children with chronic nausea
Arm Title
Control participants
Arm Type
Experimental
Arm Description
magnetogastrogram Group without any gastrointestinal diseases.
Intervention Type
Diagnostic Test
Intervention Name(s)
magnetogastrogram
Primary Outcome Measure Information:
Title
Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Measurement of gastric slow wave propagation velocity in gastroparesis patients
Time Frame
1 day
Title
Measurement of invasive serosal electromyogram before and after partial/total gastrectomy.
Time Frame
day 1 and day 30
Title
Measurement of noninvasive magnetogastrogram before and after partial/total gastrectomy.
Time Frame
day 1 and day 30
Title
Noninvasive measurement of gastric slow wave dysrhythmia in pediatric patients with nausea and functional dyspepsia
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard A Bradshaw, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26839980
Citation
Bradshaw LA, Cheng LK, Chung E, Obioha CB, Erickson JC, Gorman BL, Somarajan S, Richards WO. Diabetic gastroparesis alters the biomagnetic signature of the gastric slow wave. Neurogastroenterol Motil. 2016 Jun;28(6):837-48. doi: 10.1111/nmo.12780. Epub 2016 Feb 3.
Results Reference
result
PubMed Identifier
26595907
Citation
Bradshaw LA, Kim JH, Somarajan S, Richards WO, Cheng LK. Characterization of Electrophysiological Propagation by Multichannel Sensors. IEEE Trans Biomed Eng. 2016 Aug;63(8):1751-9. doi: 10.1109/TBME.2015.2502065. Epub 2015 Nov 19.
Results Reference
result
PubMed Identifier
22415019
Citation
Kim JH, Pullan AJ, Bradshaw LA, Cheng LK. Influence of body parameters on gastric bioelectric and biomagnetic fields in a realistic volume conductor. Physiol Meas. 2012 Apr;33(4):545-56. doi: 10.1088/0967-3334/33/4/545. Epub 2012 Mar 14.
Results Reference
result
PubMed Identifier
24398454
Citation
Somarajan S, Cassilly S, Obioha C, Richards WO, Bradshaw LA. Effects of body mass index on gastric slow wave: a magnetogastrographic study. Physiol Meas. 2014 Feb;35(2):205-15. doi: 10.1088/0967-3334/35/2/205. Epub 2014 Jan 7.
Results Reference
result
PubMed Identifier
22735166
Citation
Somarajan S, Muszynski ND, Obioha C, Richards WO, Bradshaw LA. Biomagnetic and bioelectric detection of gastric slow wave activity in normal human subjects--a correlation study. Physiol Meas. 2012 Jul;33(7):1171-9. doi: 10.1088/0967-3334/33/7/1171. Epub 2012 Jun 27.
Results Reference
result

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Biomagnetic Characterization of Gastric Dysrhythmias III

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