Gastroparesis
Conditions
Keywords
Gastroparesis, Nausea and Vomiting, Abdominal Pain, Gastric Emptying, Electrophysiology, Hormones, Inflammation, Enteric Nervous System, Autonomic Nervous System
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.
Interventions
Temporary and permanent gastric electrical stimulation
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Louisville
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal symptoms | Change from baseline to 6 days to 6 months | By standardized symptom scoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Autonomic | Change from baseline to 6 days to 6 months | By autonomic function |
| Hormones | Change from baseline to 6 days to 6 months | By serum measures |
| Inflammation | Change from baseline to 6 days to 6 months | By serum measures |
| Gastric Emptying Test | baseline, 6 days, 6 months | By gastric emptying test |
| Electrophysiology | Change from baseline to 6 days to 6 months | By Electrogastrogram(EGG)/ Electrogram (EG) |
| Quality of life by IDIOMS | Change from baseline to 6 days to 6 months | By standardized scale |
| Gastric emptying | baseline, 6 days, 6 months | By radionuclides |
Outcome results
None listed