# New Concepts for Advancing Knowledge in Basic Science, Clinical, and Therapeutic Aspects of Gastroparesis

> **NIH NIH U01** · TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO · 2021 · $133,333

## Abstract

Abstract:
Gastroparesis (GP) presents with chronic upper GI dysmotility symptoms in the setting of delayed
gastric emptying without any mechanical obstruction. Inconsistencies exist between subjective
symptom severity and objective evidence of GP, and available therapies are limited by accompanying
adverse events and unpredictable efficacy. Hence the pathophysiology, clinical course, outcomes and
treatment strategies require further investigation. Our response to the NIDDK Gastroparesis
Consortium (U01) under RFA-DK-16-010 has the following aims:
1) To complete approved studies initiated by the GpCRC which entails enrolling GP patients to
 Gastroparesis Registry 2 with their clinical data and bio-samples as well as obtain gastric tissue
 under the pathological basis of gastroparesis (PBG) protocol, when some patients undergo surgery
 for failed medical therapy. This data collection will contribute more knowledge about pathogenesis,
 pathomorphology, symptoms severity grading, complications, treatment outcomes in patients with
 GP and gastroparesis-like presentation but normal gastric emptying.
2) As a new diagnostic strategy, we propose to determine whether endoscopic ultrasound (EUS)-
 guided core biopsy samples of antral muscularis propria in GP patients can provide sufficient tissue
 for full histologic analysis to specifically address status of interstitial cell of Cajal, myenteric plexus
 neurons and smooth muscle pathology. After reconfirming the safety and success of this
 methodology in a study of 30 patients receiving both endoscopic and surgical biopsies all patients
 entering GpR3 as well as GpR2 registry will undergo EUS guided core biopsies of the antral
 muscularis propria as part of the database. Therefore we will investigate whether this endoscopic
 method can safely replace surgery to obtain smooth muscle tissue and correlate ICC findings with
 symptoms, gastric emptying and treatment outcome.
3) We propose to investigate the therapeutic efficacy of a new Dopamine D2/D3 antagonist in
 gastroparetic patients of either diabetic or idiopathic etiology by performing a multicenter, double-
 blind, randomized, placebo-controlled, parallel three-group study which will also assess cardiac
 safety and adverse event. The plan is for the NIH to partner with one of the 2 pharmaceutical
 companies developing new agents, Dopamine D2/D3 antagonists with no cardiac toxicity. All GpR3
 patients will be invited to enroll into 2 parallel 12 week trials for diabetic and idiopathic etiologies of
gastroparesis.
 If we are awarded this grant, TTU research team is committed to facilitate the execution of the
 protocols and collaborate with other Centers under GpCRC and NIDDK/NIH supervision.

## Key facts

- **NIH application ID:** 10474230
- **Project number:** 3U01DK074035-12S2
- **Recipient organization:** TEXAS TECH UNIVERSITY HEALTH SCIENCES CENTER AT EL PASO
- **Principal Investigator:** Richard Warwick McCallum
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $133,333
- **Award type:** 3
- **Project period:** 2008-09-30 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10474230

## Citation

> US National Institutes of Health, RePORTER application 10474230, New Concepts for Advancing Knowledge in Basic Science, Clinical, and Therapeutic Aspects of Gastroparesis (3U01DK074035-12S2). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10474230. Licensed CC0.

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