Autonomic and Enteric Profiling

University of Louisville (UOFL)

Status: Completed

Conditions: Gastroparesis

Treatments: Device: Gastric Electrical Stimulation

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03178370

5U01DK074007-12 (U.S. NIH Grant/Contract)

13.0890

Details and patient eligibility

About

Autonomic, inflammatory, enteric, electrophysiologic and hormonal.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

43 participants in 2 patient groups

Diabetic Gastroparesis

Treatment:

Device: Gastric Electrical Stimulation

Idiopathic Gastroparesis

Treatment:

Device: Gastric Electrical Stimulation