GI-Challenge Study for Gastroparesis Patients and Healthy Controls

Instantaneous Measures of Autonomic Nervous System Responses to Gastrointestinal Challenges

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.

Study Overview

• Status: Recruiting
• Conditions: Gastroparesis
• Intervention / Treatment: Other: Observational

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Andres Gottfried Blackmore, MD PhD; Phone Number: 650-723-6815; Email: andresg@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University Medical Center
      • Contact: Andres Gottfried Blackmore, MD PhD; Phone Number: 650-723-6815; Email: andresg@stanford.edu
      • Principal Investigator: Linda Nguyen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

60 Patients (20 Gastroparesis and 40 Controls) between the ages of 20-49.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gastroparesis Patients; 20 gastroparesis patient ages 20-49	Other: Observational; There is no intervention. This is an observational study attempting to establish parameters of normal and abnormal vagal tone in healthy control and gastroparesis patients, as there is currently no metric to determine what dose of vagal stimulation is required to treat gastroparesis.
Healthy Controls; 40 healthy controls ages 20-49	Other: Observational; There is no intervention. This is an observational study attempting to establish parameters of normal and abnormal vagal tone in healthy control and gastroparesis patients, as there is currently no metric to determine what dose of vagal stimulation is required to treat gastroparesis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The ANSAR computes sympathovagal score by collecting sympathetic low frequency area (LFa) and parasympathetic respiratory frequency area (RFa) data (both measured as beats per minute squared, or BPM2) and calculating the ratio of these two complementary measures of the autonomic nervous system (LFa/RFa) to arrive at one aggregated score.	Single two hour visit
Determination of sympathovagal score following digestive challenges in gastroparesis patients using the ANSAR ANX 3.0 ANS Monitoring System and comparison to healthy volunteers.	The ANSAR computes sympathovagal score by collecting sympathetic low frequency area (LFa) and parasympathetic respiratory frequency area (RFa) data (both measured as beats per minute squared, or BPM2) and calculating the ratio of these two complementary measures of the autonomic nervous system (LFa/RFa) to arrive at one aggregated score.	Single two hour visit
Correlation of sympathovagal score, a measure of cardiac autonomic activity, with gastroparesis disease severity.	To determine if sympathovagal scores correlate with gastroparesis clinical disease severity using standardized GI symptom scoring - the Gastroparesis Cardinal Symptom Index consists of 10 questions that rate gastroparesis symptoms on a scale of 1 - 6 from "none" to "very severe".	Single two hour visit

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Andres C Gottfried Blackmore, MD, PhD, Stanford University; Study Chair: Linda Nguyen, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Healthy Control; Diabetic Gastroparesis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Gastroparesis
• Other Study ID Numbers: 44258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No