Autonomic and Enteric Profiling

NCT03178370 | Completed FDA Device

• 2 other identifiers: 13.08905U01DK074007-12
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief Summary

Autonomic, inflammatory, enteric, electrophysiologic and hormonal.

Conditions

Gastroparesis

Keywords

Gastroparesis; Nausea and Vomiting; Abdominal Pain; Gastric Emptying; Electrophysiology; Hormones; Inflammation; Enteric Nervous System; Autonomic Nervous System

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal symptoms

  By standardized symptom scoring

  Change from baseline to 6 days to 6 months

Secondary Outcomes (7)

• Gastric Emptying Test

  baseline, 6 days, 6 months

• Autonomic

  Change from baseline to 6 days to 6 months

• Hormones

  Change from baseline to 6 days to 6 months

• Inflammation

  Change from baseline to 6 days to 6 months

• Gastric emptying

  baseline, 6 days, 6 months

Study Arms (2)

Diabetic Gastroparesis

Device: Gastric Electrical Stimulation

Idiopathic Gastroparesis

Device: Gastric Electrical Stimulation

Interventions

Gastric Electrical Stimulation DEVICE

Temporary and permanent gastric electrical stimulation

Diabetic Gastroparesis; Idiopathic Gastroparesis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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. -

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Louisville: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Related Publications (2)

• 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.

  PMID: 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, 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.

  PMID: 30706646 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Gastroparesis; Nausea; Vomiting; Abdominal Pain; Inflammation

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Pain; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 6, 2017
• Study Start: March 6, 2014
• Primary Completion: December 3, 2015
• Study Completion: December 3, 2015
• Last Updated: October 28, 2022

Record last verified: 2022-10