Autonomic and Enteric Profiling

Autonomic and Enteric Profiling in Relation to Body Weight

Autonomic, inflammatory, enteric, electrophysiologic and hormonal.

Study Overview

• Status: Completed
• Conditions: Gastroparesis
• Intervention / Treatment: Device: Gastric Electrical Stimulation

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 Type: Observational
• Enrollment (Actual): 43

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. Willingness to participate in study and sign informed consent.
2. Age 18 or older.
3. Symptoms of gastroparesis for at least 6 months.
4. Refractory or intolerant to antiemetic drugs.
5. Refractory or intolerant to prokinetic drugs.
6. If Diabetic, documentation of medication for diabetes for at least 6 months.
7. No evidence of anatomic obstruction of GI tract. -

Exclusion Criteria:

1. Previous gastric surgery.
2. History or evidence of rumination syndrome, eating disorder of primary psychiatric disorder.
3. No know collagen vascular disease.
4. Inability or unwillingness to participate in the study.
5. Current active gastric stimulation or other gastrointestinal neurostimulation implant or device.
6. Pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diabetic Gastroparesis	Device: Gastric Electrical Stimulation; Temporary and permanent gastric electrical stimulation
Idiopathic Gastroparesis	Device: Gastric Electrical Stimulation; Temporary and permanent gastric electrical stimulation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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
Hormones	By serum measures	Change from baseline to 6 days to 6 months
Inflammation	By serum measures	Change from baseline to 6 days to 6 months
Gastric emptying	By radionuclides	baseline, 6 days, 6 months
Electrophysiology	By Electrogastrogram(EGG)/ Electrogram (EG)	Change from baseline to 6 days to 6 months
Quality of life by IDIOMS	By standardized scale	Change from baseline to 6 days to 6 months

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

General 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. Erratum In: Dig Dis Sci. 2020 Jun 8;:
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 6, 2014
• Primary Completion (ACTUAL): December 3, 2015
• Study Completion (ACTUAL): December 3, 2015

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (ACTUAL): June 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Abdominal Pain; Autonomic Nervous System; Gastroparesis; Gastric Emptying; Hormones; Electrophysiology; Enteric Nervous System; Nausea and Vomiting
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: 13.0890; 5U01DK074007-12 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: No plan in place.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes