Autonomic and Enteric Profiling

University of Louisville43 enrolled

Overview

Autonomic, inflammatory, enteric, electrophysiologic and hormonal.

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

Conditions

Gastroparesis

Interventions

Gastric Electrical StimulationDEVICE

Temporary and permanent gastric electrical stimulation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Gastrointestinal symptoms

By standardized symptom scoring

Time frame: Change from baseline to 6 days to 6 months

Secondary Outcomes

Gastric Emptying Test

By gastric emptying test

Time frame: baseline, 6 days, 6 months

Autonomic

By autonomic function

Time frame: Change from baseline to 6 days to 6 months

Hormones

By serum measures

Time frame: Change from baseline to 6 days to 6 months

Inflammation

By serum measures

Time frame: Change from baseline to 6 days to 6 months

Gastric emptying

By radionuclides

Time frame: baseline, 6 days, 6 months

Electrophysiology

By Electrogastrogram(EGG)/ Electrogram (EG)

Time frame: Change from baseline to 6 days to 6 months

Quality of life by IDIOMS

By standardized scale

Time frame: Change from baseline to 6 days to 6 months

Data from ClinicalTrials.gov

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