GastroparesisNCT03178370
Autonomic and Enteric Profiling
An observational study of Gastroparesis, run by University of Louisville.
Trial summary
Autonomic, inflammatory, enteric, electrophysiologic and hormonal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Gastric Electrical Stimulation
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2014to 3 Dec 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From 44 consecutive consented patients seen in our clinic, 43 were deemed to be eligible for the study. Those 43 patients were the basis for the baseline evaluation (part one) of this study. Of 43 patients, (description: 15 M, 28 F, mean age 46.3 years; 23 DM, 20 ID), 41 (description: 13 M, 28 F, mean age 45.7 years; 21 DM, 20 ID), finished the temporary phase of gastric electrical stimulation, and 36 (description: 11 M, 25 F, mean age 44.7 years; 18 DM, 18 ID) of those 41 were implanted with permanent GES devices. Of 36 implanted, 30 patients (description: 9 M, 21 F, mean age 43.1 years; 14 DM, 16 ID) were followed at 6 months. The entirety of the GES patients, baseline, temporary and permanent, were the basis for the stimulation portion (part two) of this study.
Who may be able to join
- Willingness to participate in study and sign informed consent.
- Age 18 or older.
- Symptoms of gastroparesis for at least 6 months.
- Refractory or intolerant to antiemetic drugs.
- Refractory or intolerant to prokinetic drugs.
- If Diabetic, documentation of medication for diabetes for at least 6 months.
- No evidence of anatomic obstruction of GI tract. -
Who cannot join
- Previous gastric surgery.
- History or evidence of rumination syndrome, eating disorder of primary psychiatric disorder.
- No know collagen vascular disease.
- Inability or unwillingness to participate in the study.
- Current active gastric stimulation or other gastrointestinal neurostimulation implant or device.
- Pregnancy.
About this study
Official title: Autonomic and Enteric Profiling in Relation to Body Weight
Autonomic, inflammatory, enteric, electrophysiologic and hormonal.
Read the detailed description
Patients were evaluated by two methods in each of five areas: inflammatory, autonomic, enteric, electrophysiologic, and hormonal.
In part one, patients had similar GI Symptoms regardless of baseline gastric emptying or diabetic/non-diabetic status and all patients demonstrated abnormalities in each of the 5 areas studied.
In part two, patients showed early and late effects of electrical stimulation with changes noted in multiple areas, categorized by improvement status.
- Conditions
- Gastroparesis
- Being tested
- Gastric Electrical Stimulation
- Keywords
- Gastroparesis, Nausea and Vomiting, Abdominal Pain, Gastric Emptying, Electrophysiology, Hormones, Inflammation, Enteric Nervous System, Autonomic Nervous System
- Medical subject headings
- Gastroparesis, Nausea, Vomiting, Abdominal Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric Electrical StimulationDevice
Temporary and permanent gastric electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Diabetic Gastroparesis | Not described Receives: Device: Gastric Electrical Stimulation | |
| Idiopathic Gastroparesis | Not described Receives: Device: Gastric Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal symptoms
By standardized symptom scoring
Measured: Change from baseline to 6 days to 6 months
Secondary outcomes (7)
Gastric Emptying Test
By gastric emptying test
Measured: baseline, 6 days, 6 months
Autonomic
By autonomic function
Measured: Change from baseline to 6 days to 6 months
Hormones
By serum measures
Measured: Change from baseline to 6 days to 6 months
Inflammation
By serum measures
Measured: Change from baseline to 6 days to 6 months
Gastric emptying
By radionuclides
Measured: baseline, 6 days, 6 months
Electrophysiology
By Electrogastrogram(EGG)/ Electrogram (EG)
Measured: Change from baseline to 6 days to 6 months
Quality of life by IDIOMS
By standardized scale
Measured: Change from baseline to 6 days to 6 months
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 start6 Mar 2014
- Primary completion3 Dec 2015
- Study completion3 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Abell, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178370
- Sponsor's protocol ID
- 13.0890
- Other IDs
- 5U01DK074007-12
- Status last verified
- Oct 2022
- First submitted
- 30 May 2017
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: No plan in place.
Publications
Abell TL, Kedar A, Stocker A, Beatty K, McElmurray L, Hughes M, Rashed H, Kennedy W, Wendelschafer-Crabb G, Yang X, Fraig M, Gobejishvili L, Omer E, Miller E, Griswold M, Pinkston C. Pathophysiology of Gastroparesis Syndromes Includes Anatomic and Physiologic Abnormalities. Dig Dis Sci. 2021 Apr;66(4):1127-1141. doi: 10.1007/s10620-020-06259-6. Epub 2020 Apr 23.
PubMed 32328893Abell TL, Kedar A, Stocker A, Beatty K, McElmurray L, Hughes M, Rashed H, Kennedy W, Wendelschafer-Crabb G, Yang X, Fraig M, Omer E, Miller E, Griswold M, Pinkston C. Gastroparesis syndromes: Response to electrical stimulation. Neurogastroenterol Motil. 2019 Mar;31(3):e13534. doi: 10.1111/nmo.13534. Epub 2019 Jan 31.
PubMed 30706646
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic and Enteric Profiling in Relation to Body Weight
- ClinicalTrials.gov ID
- NCT03178370
- Acronym / sponsor ID
- 13.0890
- Conditions
- Gastroparesis
- Keywords
- Gastroparesis, Nausea and Vomiting, Abdominal Pain, Gastric Emptying, Electrophysiology, Hormones, Inflammation, Enteric Nervous System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 6 Mar 2014 (actual)
- Primary completion
- 3 Dec 2015 (actual)
- Study completion
- 3 Dec 2015 (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.
Autonomic, inflammatory, enteric, electrophysiologic and hormonal.
Detailed description
Patients were evaluated by two methods in each of five areas: inflammatory, autonomic, enteric, electrophysiologic, and hormonal.
In part one, patients had similar GI Symptoms regardless of baseline gastric emptying or diabetic/non-diabetic status and all patients demonstrated abnormalities in each of the 5 areas studied.
In part two, patients showed early and late effects of electrical stimulation with changes noted in multiple areas, categorized by improvement status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic Gastroparesis | – | Device: Gastric Electrical Stimulation |
| Idiopathic Gastroparesis | – | Device: Gastric Electrical Stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From 44 consecutive consented patients seen in our clinic, 43 were deemed to be eligible for the study. Those 43 patients were the basis for the baseline evaluation (part one) of this study. Of 43 patients, (description: 15 M, 28 F, mean age 46.3 years; 23 DM, 20 ID), 41 (description: 13 M, 28 F, mean age 45.7 years; 21 DM, 20 ID), finished the temporary phase of gastric electrical stimulation, and 36 (description: 11 M, 25 F, mean age 44.7 years; 18 DM, 18 ID) of those 41 were implanted with permanent GES devices. Of 36 implanted, 30 patients (description: 9 M, 21 F, mean age 43.1 years; 14 DM, 16 ID) were followed at 6 months. The entirety of the GES patients, baseline, temporary and permanent, were the basis for the stimulation portion (part two) of this study.
Key inclusion criteria (7 listed)
- Willingness to participate in study and sign informed consent.
- Age 18 or older.
- Symptoms of gastroparesis for at least 6 months.
- Refractory or intolerant to antiemetic drugs.
- Refractory or intolerant to prokinetic drugs.
Key exclusion criteria (6 listed)
- Previous gastric surgery.
- History or evidence of rumination syndrome, eating disorder of primary psychiatric disorder.
- No know collagen vascular disease.
- Inability or unwillingness to participate in the study.
- Current active gastric stimulation or other gastrointestinal neurostimulation implant or device.
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 |
|---|---|---|
| Gastric Electrical StimulationTemporary and permanent gastric electrical stimulation | Device | Diabetic Gastroparesis, Idiopathic Gastroparesis |
Primary outcome
Gastrointestinal symptoms
Time frame: Change from baseline to 6 days to 6 months
By standardized symptom scoring
7 secondary outcomes
Gastric Emptying Test
Time frame: baseline, 6 days, 6 months
Autonomic
Time frame: Change from baseline to 6 days to 6 months
Hormones
Time frame: Change from baseline to 6 days to 6 months
Inflammation
Time frame: Change from baseline to 6 days to 6 months
Gastric emptying
Time frame: baseline, 6 days, 6 months
Electrophysiology
Time frame: Change from baseline to 6 days to 6 months
Quality of life by IDIOMS
Time frame: Change from baseline to 6 days to 6 months
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 28 Oct 2022.
- Derived from this study: PubMed 32328893Abell TL, Kedar A, Stocker A, Beatty K, McElmurray L, Hughes M, Rashed H, Kennedy W, Wendelschafer-Crabb G, Yang X, Fraig M, Gobejishvili L, Omer E, Miller E, Griswold M, Pinkston C. Pathophysiology of Gastroparesis Syndromes Includes Anatomic and Physiologic Abnormalities. Dig Dis Sci. 2021 Apr;66(4):1127-1141. doi: 10.1007/s10620-020-06259-6. Epub 2020 Apr 23.
- Derived from this study: PubMed 30706646Abell TL, Kedar A, Stocker A, Beatty K, McElmurray L, Hughes M, Rashed H, Kennedy W, Wendelschafer-Crabb G, Yang X, Fraig M, Omer E, Miller E, Griswold M, Pinkston C. Gastroparesis syndromes: Response to electrical stimulation. Neurogastroenterol Motil. 2019 Mar;31(3):e13534. doi: 10.1111/nmo.13534. Epub 2019 Jan 31.
- Individual participant dataSharing planned: Undecided. No plan in place.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis, run by University of Louisville.
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 7 inclusion and 6 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 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Gastrointestinal symptoms (time frame: Change from baseline to 6 days to 6 months). 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 NCT03178370, which also lists 2 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 28 Oct 2022.