# Exploration of Subtypes of Gastroparesis and Gastroparesis-like Symptoms based on Physiological Testing

> **NIH NIH U01** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2022 · $387,500

## Abstract

Project Summary
This project includes the continuation of studies currently conducted by NIDDK Gastroparesis
Clinical Research Consortium (GpCRC) and one new protocol proposed by this site that is to be
carried out by the Consortium. The mission of the GpCRC is to improve understanding of the
pathogenesis, etiology, and treatment of symptoms associated with GP. Improved precision in
diagnostic and therapeutic approaches are needed for patients with GP and for patients with GP-
like symptoms with normal gastric emptying, a disorder termed functional dyspepsia or FD in this
project. Thus, our aims are: 1) to continue the important studies that were begun in the third funding
period (Gastroparesis Registry 3 or GpR3); 2) to further define major subtypes of GP by measuring
gastric myoelectrical activity (GMA), gastric accommodation and sensitivity, antral – pyloro
contractility, and pyloric distensibility; and 3) to explore the efficacy of balloon dilation of the pylorus
in reducing symptoms in patients with GP and FD in a new protocol to be carried out by the
Consortium. Studies from GpR3 to be continued and completed in GpR4 include: The GP Registry,
Buspirone for Early Satiety and Symptoms of Gastroparesis: A Multicenter, Randomized, Placebo-
Controlled, Double-Masked Trial (BESST), Understanding the Pathological Basis of Gastroparesis
and Identification of the Molecular Factors Involved in its Pathogenesis (PBG) Study, and Pyloric
Sphincter Abnormalities in Patients with Gastroparesis Symptoms (PSAGS). Two subtypes of GP
and FD based on GMA in response to the water load satiety test have been identified: one with
normal 3 cpm (GMA) and the other with gastric dysrhythmias. Normal 3 cpm GMA controls normal
gastric peristaltic contractions and requires normal numbers of interstitial cells of Cajal (ICCs). ICCs
are severely depleted in GP and modestly depleted in FD. Loss of ICCs results in loss of 3 cpm
GMA and increased gastric dysrhythmias which are associated with delays in gastric emptying and
symptoms like nausea. Endoscopic pyloric therapies reduce symptoms in patients with GP and 3
cpm GMA, indicating antro-pyloro outflow dysfunction has a role in the genesis of symptoms. Our
hypothesis is that patients with GP and FD who have normal 3 cpm and poor pyloric distensibility
will have greater reduction in symptoms after balloon dilation of the pylorus compared with patients
with gastric dysrhythmias. Patients with GP (or FD) with 3 cpm GMA or gastric dysrhythmias and
poor pyloric distensibility will undergo balloon dilation of the pylorus in a single blind study.
Identifying subtypes of GP and FD based on GMA will help to provide a more rational approach for
selecting patients for pyloric therapy and improving treatment outcomes.

## Key facts

- **NIH application ID:** 10318464
- **Project number:** 2U01DK073974-16
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** KENNETH L KOCH
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $387,500
- **Award type:** 2
- **Project period:** 2006-04-15 → 2027-07-18

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10318464

## Citation

> US National Institutes of Health, RePORTER application 10318464, Exploration of Subtypes of Gastroparesis and Gastroparesis-like Symptoms based on Physiological Testing (2U01DK073974-16). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10318464. Licensed CC0.

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