Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

Urine levels of Glycated CD59 for screening and diagnosis of pregnancy-induced glucose intolerance

Award Number: R01DK136617
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2024
PERIOD OF PERFORMANCE END DATE: 02/29/2028

Group Awards By:

View Award Description

Urine levels of Glycated CD59 for screening and diagnosis of pregnancy-induced glucose intolerance - The goal of this proposal is to validate glycated CD59 (GCD59) in human urine as a novel diabetes biomarker. This validation will be conducted across several hyperglycemic conditions including pregnancy-induced glucose intolerance/gestational diabetes. The proposal is highly translational and addresses major Public Health priorities because: 1) women with pregnancy-induced glucose intolerance and their fetus are at an increased risk of adverse clinical outcomes, 2) the frequency of pregnancy-induced glucose intolerance is increasing at alarming rates, 3) appropriate treatment reduces the associated risks for mother and newborn, and 4) glucose load tests, currently the gold standard identifying pregnancy-induced glucose intolerance, are expensive, time consuming, unpleasant, and have poor reproducibility on repeat testing. These facts highlight why a simpler, shorter, easier-to-use, cost-effective, sensitive and specific test would be a much better tool to screen for pregnancy-induced glucose intolerance. The applicants have 1) discovered that human CD59 is inactivated by glycation, 2) provided evidence for a link between the complement system and the complications of diabetes, and 3) developed key reagents and established specific and sensitive assays that allows quantification of GCD59 in blood. With this assay, we have conducted several published studies including ≈4,000 subjects with diabetes, pre-diabetes or gestational diabetes. Based on the robust preliminary data from these studies and available resources, we now propose the highly focused aim of assessing the clinical utility of urine GCD59 as a simple, easy-to-use test for screening and diagnosis of diabetes, pre-diabetes and gestational diabetes. All necessary tools and expertise to accomplish our aims are available in the laboratory of the applicant and expert collaborators, including monoclonal antibodies specific for GCD59 and assay calibrators, diagnostic tools, equipment and expertise necessary to conduct all studies proposed in the application. Through the Crimson Biomaterials Collection Core Facility we have access to urine and plasma samples from ≈ 12,000 pregnant women seeking prenatal care every year at the two main Partner’s Healthcare Hospitals. Successful accomplishment of our aim will provide a clinically useful biomarker that could simplify screening, diagnosis and management of conditions characterized by hyperglycemia.


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: 2026 ( Subtotal = $719,378 )
2026	2026	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	3	3/30/2026	NON-COMPETING CONTINUATION	$719,378
														Subtotal = $719,378

Issue Date FY: 2025 ( Subtotal = $647,442 )
2025	2025	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	2	2/17/2025	NON-COMPETING CONTINUATION	$647,442
														Subtotal = $647,442

Issue Date FY: 2024 ( Subtotal = $734,290 )
2024	2024	BRIGHAM & WOMENS HOSPITAL INC	75 FRANCIS ST	BOSTON	MA	02115	SUFFOLK	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	3/25/2024	NEW	$734,290
														Subtotal = $734,290

Grand Total All Awards = $2,101,110

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Urine levels of Glycated CD59 for screening and diagnosis of pregnancy-induced glucose intolerance

Award Number: R01DK136617

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 04/01/2024

PERIOD OF PERFORMANCE END DATE: 02/29/2028

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer