Autonomic and Enteric Profiling

Study Overview
=================
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.

Official Title
-----------------
Autonomic and Enteric Profiling in Relation to Body Weight

Conditions
-----------------
Gastroparesis

Intervention / Treatment
-----------------
* Device: Gastric Electrical Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. - Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diabetic Gastroparesis<br> | Device: Gastric Electrical Stimulation<br>* Temporary and permanent gastric electrical stimulation<br>|
| Idiopathic Gastroparesis<br> | Device: Gastric Electrical Stimulation<br>* Temporary and permanent gastric electrical stimulation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal symptoms | By standardized symptom scoring | Change from baseline to 6 days to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric Emptying Test | By gastric emptying test | baseline, 6 days, 6 months | 
| Autonomic | By autonomic function | Change from baseline to 6 days to 6 months | 
| Hormones | By serum measures | Change from baseline to 6 days to 6 months | 
| Inflammation | By serum measures | Change from baseline to 6 days to 6 months | 
| Gastric emptying | By radionuclides | baseline, 6 days, 6 months | 
| Electrophysiology | By Electrogastrogram(EGG)/ Electrogram (EG) | Change from baseline to 6 days to 6 months | 
| Quality of life by IDIOMS | By standardized scale | Change from baseline to 6 days to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroparesis, Nausea and Vomiting, Abdominal Pain, Gastric Emptying, Electrophysiology, Hormones, Inflammation, Enteric Nervous System, Autonomic Nervous System