# Biomarker of IAPP dysfunction in prediabetes and early type 2 diabetes mellitus (T2DM)

> **NIH NIH R43** · CELDARA MEDICAL, LLC · 2020 · $299,152

## Abstract

Project Summary
Type 2 diabetes mellitus (T2DM) is a major unmet public health concern with an annual cost in the United States
of over 300 billion dollars, according to the American Diabetes Association. Approximately 25% of the U.S.
population is considered prediabetic, or at high risk of developing T2DM. Human islet amyloid polypeptide
(hIAPP, or amylin) is a pancreatic hormone co-expressed and secreted with insulin in response to high glucose
concentrations. hIAPP has a strong propensity to misfold and aggregate, causing amyloid formation in the islets
which results in pancreatic β-cell death and decreased insulin secretion. A significant unmet challenge
associated with early detection of hIAPP aggregates is the ability to detect misfolded hIAPP protein versus the
natively folded and functional monomeric peptides.
In this Phase I application we will develop a first in-kind assay derived from our innovative ‘cap and trap’
technology that provides the capacity to discriminate between misfolded hIAPP and native functional amylin.
From this platform we will identify the top 3 highest affinity monoclonal antibodies that will be utilized for an
ELISA-based diagnostic in order allow early detection of amyloidogenic hIAPP prior to complete amyloid-
dependent β-cell toxicity and insulin-dependent T2DM. The assay will be designed to specifically recognize and
quantitate levels of protofibril as opposed to native hIAPP in blood samples of prediabetic and diabetic patients.
The immediate impact on the patient population will be the early detection of pathogenic β-cell-derived amyloid
protofibrils as a new indicator of prediabetes or early signs of T2DM, as well as a valuable assay for monitoring
the effectiveness of drug or dietary interventions.

## Key facts

- **NIH application ID:** 10079720
- **Project number:** 1R43DK125161-01A1
- **Recipient organization:** CELDARA MEDICAL, LLC
- **Principal Investigator:** PAUL GUYRE
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $299,152
- **Award type:** 1
- **Project period:** 2020-09-11 → 2022-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10079720

## Citation

> US National Institutes of Health, RePORTER application 10079720, Biomarker of IAPP dysfunction in prediabetes and early type 2 diabetes mellitus (T2DM) (1R43DK125161-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10079720. Licensed CC0.

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