Clinical trial NCT03896126: GI-Challenge Study for Gastroparesis Patients and Healthy Controls
Official title: Instantaneous Measures of Autonomic Nervous System Responses to Gastrointestinal Challenges
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastroparesis
Keywords: Healthy Control
Diabetic Gastroparesis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 Patients (20 Gastroparesis and 40 Controls) between the ages of 20-49.

Brief summary: Gastroparesis Patients and Healthy Controls ages 20-49 will be asked to participate in an observational study measuring vagal activity following food ingestion in order to establish parameters of autonomic nerve/vagal function in healthy human subjects compared to those with gastroparesis. Information generated from this study may be used in the future to establish what is normal and abnormal enteric vagal tone and how much vagal nerve stimulation treatment may be required to help patients with gastroparesis.

Detailed description: Impaired function of the vagus nerve has been documented in many chronic diseases such as diabetes, heart disease, and chronic pain, as well as gastrointestinal diseases such as irritable bowel syndrome, inflammatory bowel disease, and delayed stomach emptying (gastroparesis).

Current technology only allows for measurement of vagal nerve activity that regulates the heart and diagnostic tests focus specifically on cardiac vagal activity. Measuring vagal nerve activity as it pertains to the gastrointestinal system is an unmet medical need. Its importance will continue to grow since vagal nerve stimulation is being used increasingly in a myriad of different diseases, and currently there is no way of knowing if patients are getting too little or too much stimulation.

In this study, the gastrointestinal vagus nerve will be activated using normal stimulants like food ingestion and vagal activity will be measured using current non-invasive technology. Patients with gastroparesis and healthy controls will be asked to come in fasting, fill out surveys, and complete eating challenges while being connected to an autonomic function testing machine. Exploratory outcomes will also be measured - Participants will be connected to a Peripheral Intravenous Line in order to collect four vials of blood throughout the two hour clinic visit so that hormonal changes can be studied. Also, exploratory non-invasive electrogastrograms will be recorded remotely both during the autonomic function test and for three consecutive days as participants go about their daily lives.

The investigators' goal is to establish a protocol for measuring gastrointestinal evoked vagal activity and correlating activity with digestive function in both healthy people and gastroparesis patients.

Eligibility criteria: Inclusion Criteria

1. Male or female.
2. Age 20-49 years old.
3. Healthy volunteer or established diagnosis of idiopathic gastroparesis as per AGA (American Gastroenterology Association) guidelines.
4. Participant is capable of giving informed consent.
5. Gastroparesis patients must be on stable doses of medications for gastroparesis for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).

Exclusion criteria.

1. Diagnosis of systemic autonomic nerve dysfunction (i.e. POTS, CAN).
2. Surgical-related gastroparesis
3. Extrinsic myopathy or neuropathy causing gastroparesis.
4. Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
5. Patients with enteric feeding tubes or requiring parenteral nutrition.
6. Patients with severe disease flare requiring hospitalization or frequent emergency room visits (last within 3 months or less of enrollment).
7. Untreated significant depression or suicidal thoughts.
8. Pregnant or breast-feeding women.
9. History of gastric pacemaker implantation.
10. Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, pyloroplasty, or gastric bypass.
11. Patients with implantable electronic devices.
12. Dairy, wheat, or egg allergy/intolerance.
13. Allergy to commercial clinical adhesive for EKG stickers.
14. Non-English speaker and/or hearing impaired (as participants need to follow English verbal commands and cues for the experiment).

Primary outcomes:
measure: Determination of sympathovagal score, a measure of cardiac autonomic activity, following digestive challenges in healthy volunteers using the FDA-approved ANSAR ANX 3.0 Autonomic Nervous System (ANS) Monitoring System.
timeFrame: Single two hour visit
measure: Determination of sympathovagal score following digestive challenges in gastroparesis patients using the ANSAR ANX 3.0 ANS Monitoring System and comparison to healthy volunteers.
timeFrame: Single two hour visit
measure: Correlation of sympathovagal score, a measure of cardiac autonomic activity, with gastroparesis disease severity.
timeFrame: Single two hour visit
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Andres C Gottfried Blackmore, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Linda Nguyen, MD
role: STUDY_CHAIR
References: