Diabetics Without Symptoms of GastroparesisEarly Phase 1NCT03176927
Biomagnetic Characterization of Gastric Dysrhythmias III
A Early Phase 1 study testing magnetogastrogram in people with Diabetics Without Symptoms of Gastroparesis and Diabetic Gastroparesis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetics Without Symptoms of Gastroparesis, Diabetic Gastroparesis, Idiopathic Gastroparesis
- What is being tested?
- magnetogastrogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2012to 19 May 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
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.
Read the detailed description
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.
- Conditions
- Diabetics Without Symptoms of Gastroparesis, Diabetic Gastroparesis, Idiopathic Gastroparesis, Total or Partial Gastrectomy, Chronic Nausea, Functional Dyspepsia
- Being tested
- magnetogastrogram
- Keywords
- magnetogastrogram, gastroparesis, electrogastrogram, gastric slow wave
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetogastrogramDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Gastroparesis | Experimental | magnetogastrogram
Diabetes with and without gastroparesis ; Idiopathic gastroparesis Receives: Diagnostic Test: magnetogastrogram |
| Gastrectomy | Experimental | magnetogastrogram
Total or partial gastrectomy group Receives: Diagnostic Test: magnetogastrogram |
| Functional dyspepsia | Experimental | magnetogastrogram
Children with functional dyspepsia Receives: Diagnostic Test: magnetogastrogram |
| Chronic nausea | Experimental | magnetogastrogram
Children with chronic nausea Receives: Diagnostic Test: magnetogastrogram |
| Control participants | Experimental | magnetogastrogram
Group without any gastrointestinal diseases. Receives: Diagnostic Test: magnetogastrogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach
Measured: 1 day
Secondary outcomes (4)
Measurement of gastric slow wave propagation velocity in gastroparesis patients
Measured: 1 day
Measurement of invasive serosal electromyogram before and after partial/total gastrectomy.
Measured: day 1 and day 30
Measurement of noninvasive magnetogastrogram before and after partial/total gastrectomy.
Measured: day 1 and day 30
Noninvasive measurement of gastric slow wave dysrhythmia in pediatric patients with nausea and functional dyspepsia
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start28 Dec 2012
- Primary completion19 May 2021
- Study completion19 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetics Without Symptoms of GastroparesisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Bradshaw, Vanderbilt University Medical Center
- Investigators
- Leonard A Bradshaw, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176927
- Sponsor's protocol ID
- IRB# 121501
- Other IDs
- R01DK058697
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2017
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26839980Bradshaw 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.
PubMed 26595907Kim 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.
PubMed 22415019Somarajan 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.
PubMed 24398454Somarajan 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.
PubMed 22735166
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomagnetic Characterization of Gastric Dysrhythmias III
- ClinicalTrials.gov ID
- NCT03176927
- Acronym / sponsor ID
- IRB# 121501
- Conditions
- Diabetics Without Symptoms of Gastroparesis, Diabetic Gastroparesis, Idiopathic Gastroparesis, Total or Partial Gastrectomy, Chronic Nausea, Functional Dyspepsia
- Keywords
- magnetogastrogram, gastroparesis, electrogastrogram, gastric slow wave
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 28 Dec 2012 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Gastroparesis | Experimental | Diagnostic Test: magnetogastrogrammagnetogastrogram Diabetes with and without gastroparesis ; Idiopathic gastroparesis |
| Gastrectomy | Experimental | Diagnostic Test: magnetogastrogrammagnetogastrogram Total or partial gastrectomy group |
| Functional dyspepsia | Experimental | Diagnostic Test: magnetogastrogrammagnetogastrogram Children with functional dyspepsia |
| Chronic nausea | Experimental | Diagnostic Test: magnetogastrogrammagnetogastrogram Children with chronic nausea |
| Control participants | Experimental | Diagnostic Test: magnetogastrogrammagnetogastrogram Group without any gastrointestinal diseases. |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| magnetogastrogram | Diagnostic test | Chronic nausea, Control participants, Functional dyspepsia, Gastrectomy, Gastroparesis |
Primary outcome
Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach
Time frame: 1 day
4 secondary outcomes
Measurement of gastric slow wave propagation velocity in gastroparesis patients
Time frame: 1 day
Measurement of invasive serosal electromyogram before and after partial/total gastrectomy.
Time frame: day 1 and day 30
Measurement of noninvasive magnetogastrogram before and after partial/total gastrectomy.
Time frame: day 1 and day 30
Noninvasive measurement of gastric slow wave dysrhythmia in pediatric patients with nausea and functional dyspepsia
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 26839980Bradshaw 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 publication: PubMed 26595907Bradshaw 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 publication: PubMed 22415019Kim 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 publication: PubMed 24398454Somarajan 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 publication: PubMed 22735166Somarajan 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard A Bradshaw, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing magnetogastrogram in people with Diabetics Without Symptoms of Gastroparesis and Diabetic Gastroparesis, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of gastric slow wave activity in normal and diseased smooth muscle of the stomach (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03176927, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.