Autonomic and Enteric Profiling | NCT03178370

Studies
Autonomic and Enteric Profiling

NCT03178370

Sponsor

University of Louisville

Status

Completed

Last Update Posted

Oct 28, 2022Actual

Enrollment

43Actual

Phase

Not provided

Conditions

Gastroparesis

Interventions

Gastric Electrical Stimulation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5U01DK074007-12	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2014Actual

Primary Completion Date

Dec 3, 2015Actual

Completion Date

Dec 3, 2015Actual

First Submitted Date

May 30, 2017

First Submission Date that Met QC Criteria

Jun 5, 2017

First Posted Date

Jun 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2022

Last Update Posted Date

Oct 28, 2022Actual

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

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

43Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetic Gastroparesis			Device: Gastric Electrical Stimulation
Idiopathic Gastroparesis			Device: Gastric Electrical Stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gastric Electrical Stimulation	Device	Temporary and permanent gastric electrical stimulation	Diabetic Gastroparesis Idiopathic Gastroparesis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Gastrointestinal symptoms	By standardized symptom scoring	Change from baseline to 6 days to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Gastric Emptying Test	By gastric emptying test	baseline, 6 days, 6 months
Autonomic	By autonomic function	Change from baseline to 6 days to 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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. -

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32328893	Derived	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.
30706646	Derived	Abell 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.

ID	Term
D018589	Gastroparesis
D009325	Nausea
D014839	Vomiting
D015746	Abdominal Pain
D007249	Inflammation

ID	Term
D013272	Stomach Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010243	Paralysis