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GI-Challenge Study for Gastroparesis Patients and Healthy Controls

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ClinicalTrials.gov Identifier: NCT03896126
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 8, 2021
Sponsor:
Information provided by (Responsible Party):
Andres Gottfried, Stanford University

Tracking Information
First Submitted Date March 15, 2019
First Posted Date March 29, 2019
Last Update Posted Date March 8, 2021
Actual Study Start Date January 1, 2019
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2019)
  • 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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".
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title GI-Challenge Study for Gastroparesis Patients and Healthy Controls
Official Title Instantaneous Measures of Autonomic Nervous System Responses to Gastrointestinal Challenges
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 60 Patients (20 Gastroparesis and 40 Controls) between the ages of 20-49.
Condition Gastroparesis
Intervention 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.
Study Groups/Cohorts
  • Gastroparesis Patients
    20 gastroparesis patient ages 20-49
    Intervention: Other: Observational
  • Healthy Controls
    40 healthy controls ages 20-49
    Intervention: Other: Observational
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 27, 2019)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
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).
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 49 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Brittany Marsh 650-723-6815 brimarsh@stanford.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03896126
Other Study ID Numbers 44258
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Andres Gottfried, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Andres C Gottfried Blackmore, MD, PhD Stanford University
Study Chair: Linda Nguyen, MD Stanford University
PRS Account Stanford University
Verification Date March 2021