Autonomic and Enteric Profiling

Gastroparesis Clinical Trial

Official title:

Autonomic and Enteric Profiling in Relation to Body Weight

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03178370
• Other study ID #: 13.0890
• Secondary ID: 5U01DK074007-12
• Status: Completed
• Start date: March 6, 2014
• Est. completion date: December 3, 2015

Study information

• Verified date: October 2022
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Autonomic, inflammatory, enteric, electrophysiologic and hormonal.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 3, 2015
• Est. primary completion date: December 3, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Device:
• Gastric Electrical Stimulation
Temporary and permanent gastric electrical stimulation

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal symptoms	By standardized symptom scoring	Change from baseline to 6 days to 6 months
Secondary	Gastric Emptying Test	By gastric emptying test	baseline, 6 days, 6 months
Secondary	Autonomic	By autonomic function	Change from baseline to 6 days to 6 months
Secondary	Hormones	By serum measures	Change from baseline to 6 days to 6 months
Secondary	Inflammation	By serum measures	Change from baseline to 6 days to 6 months
Secondary	Gastric emptying	By radionuclides	baseline, 6 days, 6 months
Secondary	Electrophysiology	By Electrogastrogram(EGG)/ Electrogram (EG)	Change from baseline to 6 days to 6 months
Secondary	Quality of life by IDIOMS	By standardized scale	Change from baseline to 6 days to 6 months