GI-Challenge Study for Gastroparesis Patients and Healthy Controls

Recruiting

• Conditions: Gastroparesis
• Interventions: Other: Observational

• Registration Number: NCT03896126
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2025-08-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastroparesis Patients	Observational	20 gastroparesis patient ages 20-49
Healthy Controls	Observational	40 healthy controls ages 20-49

Primary Outcome Measures

Name	Time	Method
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.	Single two hour visit	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.
Determination of sympathovagal score following digestive challenges in gastroparesis patients using the ANSAR ANX 3.0 ANS Monitoring System and comparison to healthy volunteers.	Single two hour visit	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.
Correlation of sympathovagal score, a measure of cardiac autonomic activity, with gastroparesis disease severity.	Single two hour visit	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".

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States