# Indiana University (IU) Clinical Center for Chronic Pancreatitis Clinical Research Network

> **NIH NIH U01** · INDIANA UNIVERSITY INDIANAPOLIS · 2020 · $473,661

## Abstract

PROJECT SUMMARY / ABSTRACT
Chronic pancreatitis (CP) is a progressive disease, often leading to loss of exocrine and endocrine
function and debilitating abdominal pain. It is unknown why some individuals progress and
develop complications, including pancreatogenic diabetes (T3cDM) and/or pancreas cancer
(PDAC). In this Consortium, investigators have proposed and initiated several well-powered
studies of risk factors, environmental influences, and proof-of-concept studies to move the field
forward, particularly those factors that increase the risk of T3cDM and PDAC. Many of these
studies are ongoing, while new innovative proposals will address other research objectives
identified by the participating NIH institutes. We propose several specific aims (SA) to meet the
goals of RFA-DK-19-009. In SA #1, we propose to continue the CPDPC's three main longitudinal
studies: PROCEED, INSPPIRE 2 and NOD, as well as those two studies designed to better define
and characterize T3cDM, DETECT and DEPICT. In SA #2, we propose to continue the ancillary
study begun during the first funding cycle, specifically MINIMAP. SA #3: Galectin-3 (Gal-3) is a
carbohydrate-binding protein which appears to be involved in fibrogenesis and tissue remodeling
in CP. A Gal-3 inhibitor is safe and shows potential for reducing hepatic fibrosis in non-alcoholic
steatohepatitis. We propose to test the hypothesis that a Gal-3 inhibitor is safe and efficacious in
patients with CP, and may reverse or halt the fibrosis observed in CP. We will evaluate changes
in pancreatic fibrosis as assessed by MRI, as well as serum and pancreatic fluid exploratory
biomarkers. In SA #4, we propose innovative studies evaluating different strategies and
interventions focused on alleviating abdominal pain in CP patients. Lacosamide, an anti-epileptic
drug, appears to inhibit opioid-induced hyperalgesia. In SA #4a, we will perform a dose-escalation
trial to evaluate the safety and tolerability of adding lacosamide to opioid therapy, followed by a
pilot randomized trial to obtain preliminary data regarding change in pain control, opioid use and
quality of life after adding lacosamide to an opioid. SA #4b: Quantitative sensory testing (QST)
uses electrical and pressure stimulation at different dermatomes in order to unravel the pain
system. We will investigate: (i) the association between QST profiles and demographic and
clinical characteristics in patients with suspected or definite CP; (ii) whether the QST profile can
be used to predict the clinical outcome of endoscopic or surgical treatment. SA #4c: Pancreatic
duct stones may complicate CP, contributing to abdominal pain, and removal of these stones at
ERCP frequently leads to significant pain relief. In this proposal, we compare the efficacy of two
adjunctive procedures to ERCP for the treatment of main pancreatic duct stones in painful CP.

## Key facts

- **NIH application ID:** 10073887
- **Project number:** 2U01DK108323-06
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Evan L Fogel
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $473,661
- **Award type:** 2
- **Project period:** 2015-09-28 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10073887

## Citation

> US National Institutes of Health, RePORTER application 10073887, Indiana University (IU) Clinical Center for Chronic Pancreatitis Clinical Research Network (2U01DK108323-06). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10073887. Licensed CC0.

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