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

Award Number: R43DK125161
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	CELDARA MEDICAL, LLC	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	6/7/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	CELDARA MEDICAL, LLC	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	12/22/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $299,152 )
2020	2020	CELDARA MEDICAL, LLC	16 CAVENDISH CT	LEBANON	NH	03766	GRAFTON	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/11/2020	NEW	$299,152
														Subtotal = $299,152

Grand Total All Awards = $299,152

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

Award Number: R43DK125161

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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