# Blood Levels of Glycated CD59, a Novel Biomarker to Assess Pregnancy-induced Glucose Intolerance

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2020 · $697,796

## Abstract

Project Summary/Abstract –
The goal of this proposal is to validate glycated CD59 (GCD59) in human blood as a novel biomarker to
screen for studies of pregnancy-induced glucose intolerance. This 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 and perinatal complications, 2) the
frequency of pregnancy-induced glucose intolerance is increasing at alarming rates, 3) epidemiological studies
have shown that appropriate treatment reduces the associated risks for the mother and newborn, and 4) the
glucose load tests, currently the gold standard identifying pregnancy-induced glucose intolerance, are
expensive, time consuming, non-physiologic and unpleasant, have poor reproducibility on repeat testing.
These facts highlight why there is agreement that 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 pathogenesis of the complications of diabetes, and 3)
developed key reagents and established a specific and sensitive assay that allows quantification of GCD59
in blood. With this assay, we have conducted pilot studies in pregnant women undergoing glucose-
loading tests to screen for GDM. The results showed that a single measurement of plasma GCD59 at week ≈
24-26 predicted pregnancy-induced glucose intolerance and GDM with high specificity and sensitivity (ROC
AUC: 0.93). Based on these robust preliminary data and available resources, we now propose the highly
focused aim of prospectively studying a large cohort of pregnant women to assess the utility of GCD59 as a
simple, easy-to-use test for early prediction of pregnancy-induced glucose intolerance.
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, access to
plasma samples from a large and diverse population of pregnant women undergoing standard of care
screening for GDM, diagnostic tools, equipment and expertise necessary to conduct all studies proposed
in the application.
Successful accomplishment of our aim will provide a clinically useful and independent predictor to
investigate pregnancy-induced glucose intolerance that could simplify the earlier screening and diagnosis of
this condition.

## Key facts

- **NIH application ID:** 9902416
- **Project number:** 5R01DK118528-02
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** JOSE A HALPERIN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $697,796
- **Award type:** 5
- **Project period:** 2019-04-01 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9902416

## Citation

> US National Institutes of Health, RePORTER application 9902416, Blood Levels of Glycated CD59, a Novel Biomarker to Assess Pregnancy-induced Glucose Intolerance (5R01DK118528-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9902416. Licensed CC0.

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