Clinical trial NCT03178370: Autonomic and Enteric Profiling
Official title: Autonomic and Enteric Profiling in Relation to Body Weight
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroparesis
Keywords: Gastroparesis
Nausea and Vomiting
Abdominal Pain
Gastric Emptying
Electrophysiology
Hormones
Inflammation
Enteric Nervous System
Autonomic Nervous System
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-06-06
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastrointestinal symptoms
timeFrame: Change from baseline to 6 days to 6 months
Secondary outcomes:
measure: Gastric Emptying Test
timeFrame: baseline, 6 days, 6 months
measure: Autonomic
timeFrame: Change from baseline to 6 days to 6 months
measure: Hormones
timeFrame: Change from baseline to 6 days to 6 months
measure: Inflammation
timeFrame: Change from baseline to 6 days to 6 months
measure: Gastric emptying
timeFrame: baseline, 6 days, 6 months
measure: Electrophysiology
timeFrame: Change from baseline to 6 days to 6 months
measure: Quality of life by IDIOMS
timeFrame: Change from baseline to 6 days to 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.