---
title: "Glycated CD59 (pGCD59) as a Biomarker for Gestational Diabetes"
id: "pubmed-42013312"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42013312"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42013312/"
doi: "10.1210/endrev/bnag010"
published_at: "2026-09-16T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Glycated CD59 (pGCD59) as a Biomarker for Gestational Diabetes
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42013312
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42013312/)
- **DOI:** [10.1210/endrev/bnag010](https://doi.org/10.1210%2Fendrev%2Fbnag010)
- **Published At:** 2026-09-16T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- Gestational diabetes mellitus (GDM) is glucose intolerance that begins during pregnancy and increases risk of adverse maternal and fetal outcomes, as well as long-term cardiometabolic disease for mother and child. - Diagnosis currently relies on oral glucose tolerance tests (**OGTT**), typically at 24–28 weeks; OGTTs are burdensome, uncomfortable, and can limit universal screening uptake. - Conventional glycemic markers (for example, **HbA1c**) have shown low sensitivity for diagnosing GDM in pregnancy. - The authors describe the discovery, assay development, and clinical validation of plasma **glycated CD59 (pGCD59)** — the glucose-modified form of the complement inhibitor **CD59** — as a candidate biomarker for screening, diagnosis, and monitoring of GDM. - The review summarizes evidence from six human studies that evaluated pGCD59 performance, including analyses of probability density functions, ROC curves adjusted for maternal covariates, and associations between early-pregnancy pGCD59 and later outcomes like large-for-gestational-age (LGA) newborns. - Figures in the article show pGCD59 distributions in control versus failed glucose challenge test (GLT) and GDM groups, adjusted and unadjusted ROC curves, and comparisons between pGCD59 and HbA1c in early pregnancy. - pGCD59 has been investigated as an early marker (<20 weeks) with reported associations with subsequent GDM diagnosis and with LGA prevalence in archival cohorts. - The review highlights potential clinical applications of pGCD59 for better-tolerated, sensitive screening and for monitoring response to treatment, while noting that the review summarizes existing studies rather than presenting new randomized trial data. - Details on exact diagnostic thresholds, sensitivities, specificities, and AUC values are presented in the cited figures and original studies; the abstract summarizes the overall validation across multiple human cohorts. - The review situates pGCD59 research within broader efforts to find accurate, well-tolerated alternatives to OGTT for GDM detection and management.
## Clinical Analysis & Structured Key Points
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Affiliations Expand ### Affiliations * 1 Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. * 2 Department of Biostatistics, University of Granada, Granada, Spain. * PMID: **42013312** * PMCID: [ PMC13577763 ](https://pmc.ncbi.nlm.nih.gov/articles/PMC13577763/) * DOI: [ 10.1210/endrev/bnag010 ](https://doi.org/10.1210/endrev/bnag010) Item in Clipboard Review # Glycated CD59: a novel biomarker for gestational diabetes Michelle Toth Castillo et al. Endocr Rev. 2026. Show details Display options Display options Format Abstract PubMed PMID Endocr Rev Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22Endocr+Rev%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22Endocr+Rev%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42013312/) . 2026 Sep 16;47(5):565-576. doi: 10.1210/endrev/bnag010. ### Authors [Michelle Toth Castillo](https://pubmed.ncbi.nlm.nih.gov/?term=Toth+Castillo+M&cauthor_id=42013312)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42013312/#short-view-affiliation-1 "Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA."), [Shauntina Drayton Powell](https://pubmed.ncbi.nlm.nih.gov/?term=Drayton+Powell+S&cauthor_id=42013312)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42013312/#short-view-affiliation-1 "Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA."), [Amy Biermann](https://pubmed.ncbi.nlm.nih.gov/?term=Biermann+A&cauthor_id=42013312)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42013312/#short-view-affiliation-1 "Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA."), [Julia Torrey](https://pubmed.ncbi.nlm.nih.gov/?term=Torrey+J&cauthor_id=42013312)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42013312/#short-view-affiliation-1 "Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA."), [Miguel Angel Luque-Fernandez](https://pubmed.ncbi.nlm.nih.gov/?term=Luque-Fernandez+MA&cauthor_id=42013312)[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42013312/#short-view-affiliation-2 "Department of Biostatistics, University of Granada, Granada, Spain."), [Jose Halperin](https://pubmed.ncbi.nlm.nih.gov/?term=Halperin+J&cauthor_id=42013312)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42013312/#short-view-affiliation-1 "Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.") ### Affiliations * 1 Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. * 2 Department of Biostatistics, University of Granada, Granada, Spain. * PMID: **42013312** * PMCID: [ PMC13577763 ](https://pmc.ncbi.nlm.nih.gov/articles/PMC13577763/) * DOI: [ 10.1210/endrev/bnag010 ](https://doi.org/10.1210/endrev/bnag010) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract Gestational diabetes mellitus (GDM), defined as glucose intolerance that starts during pregnancy, represents a major public health challenge because it is a major cause of adverse maternal and fetal outcomes and presents a significantly high risk of diabetes, obesity, and cardiovascular disease for both the mother and the infant. The diagnosis of GDM is currently made through oral glucose tolerance tests (OGTT); other markers of glycemic control have notably failed for GDM diagnosis. Since the treatment of GDM reduces the incidence of adverse pregnancy outcomes, screening for GDM with OGTTs in pregnancy weeks 24 to 28 is the standard of care in most nations worldwide. However, universal screening is difficult to achieve due, in part, to the fact that OGTTs are cumbersome and uncomfortable. Thus, the importance of detecting glucose intolerance in pregnant women, the possibility of reducing with treatment the associated risks, the low sensitivity of glycemic markers in pregnancy, and the multiple problems associated with OGTTs highlight the significance of exploring alternative screening/diagnostic methods that are sensitive, accurate, and well-tolerated by patients. In this review, we summarize our discovery, development, and clinical validation in six human studies of plasma glycated CD59 (pGCD59), the glucose-modified form of the key complement inhibitor CD59, as a biomarker for screening, diagnosis, and monitoring of GDM. **Keywords:** CD59 and glycated CD59; biomarkers; complement system; gestational diabetes mellitus; pregnancy-induced glucose intolerance. © The Author(s) 2026. Published by Oxford University Press on behalf of the Endocrine Society. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Figures [ ![Figure 1](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd7b/13577763/0b3f4b8faa48/bnag010f1.gif) ](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd7b/13577763/f9f8212cff20/bnag010f1.webp) ** Figure 1 ** Convergence of the classical, lectin,… ** Figure 1 ** Convergence of the classical, lectin, and alternative complement activation pathways on the terminal… **Figure 1** Convergence of the classical, lectin, and alternative complement activation pathways on the terminal complement cascade that leads to the formation of the MAC. The picture also depicts how CD59 inhibits the final assembly of the MAC by binding to the C5b678 complex, thus restricting C9 binding and polymerization (Adapted from Ghosh et al (43), Fig. 1). The _inset_ depicts the NMR structure of human CD59, highlighting the glycation-prone motif formed by amino acid residues Lys41 (red) and His 44 (green), as well as the W40 residue that is essential for the MAC-inhibitory activity of CD59. [ ![Figure 2](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd7b/13577763/57cbacf442ff/bnag010f2.gif) ](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd7b/13577763/8d41e1f6d137/bnag010f2.webp) ** Figure 2 ** pGCD59 probability density functions between… ** Figure 2 ** pGCD59 probability density functions between control vs failed GLT subjects (A) and control… **Figure 2** pGCD59 probability density functions between control vs failed GLT subjects (A) and control vs GDM subjects (B). The red dotted lines indicate the median pGCD59 values for the respective groups. The difference in median values between two groups and 95% CIs are shown in the figure. n = 1000 (Reproduced from Ghosh et al (99), Fig. 1A and 1B). [ ![Figure 3](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd7b/13577763/3823631c8c4c/bnag010f3.gif) ](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd7b/13577763/1a3324917728/bnag010f3.webp) ** Figure 3 ** ROC curves by control vs… ** Figure 3 ** ROC curves by control vs failed GLT (A) and by control vs GDM… **Figure 3** ROC curves by control vs failed GLT (A) and by control vs GDM subjects (B). ROC curves were computed and adjusted for maternal age, BMI, race/ethnicity, multiplicity, and gestational age at pGCD59 determination and history of diabetes. **_Dashed lines,_** ROC curves adjusted for maternal age, race/ethnicity, BMI, gestation week at pGCD59 determination, and a history of diabetes. The adjusted AUCs, sensitivity, and specificity with 95% CI. **_Solid lines_** , unadjusted ROC curves. n = 1000 (Reproduced from Ghosh et al (99), Fig. 1C and 1D). [ ![Figure 4](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd7b/13577763/a28c57e1cd90/bnag010f4.gif) ](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd7b/13577763/30cbac0754fb/bnag010f4.webp) ** Figure 4 ** Comparison of pGCD59 and HbA1c… ** Figure 4 ** Comparison of pGCD59 and HbA1c ROC curves by non-GDM or GDM status diagnosed… **Figure 4** Comparison of pGCD59 and HbA1c ROC curves by non-GDM or GDM status diagnosed by OGTT testing at <20 weeks at pregnancy in the DALI study (reproduced from Ma et al (111), Fig. 2B). [ ![Figure 5](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd7b/13577763/70b267d4c28d/bnag010f5.gif) ](https://cdn.ncbi.nlm.nih.gov/pmc/blobs/dd7b/13577763/0f830b10b4ac/bnag010f5.webp) ** Figure 5 ** Trend of the association between… ** Figure 5 ** Trend of the association between maternal levels of pGCD59 at pregnancy week <… **Figure 5** Trend of the association between maternal levels of pGCD59 at pregnancy week <20 and the prevalence of LGA in archival samples from 693 DALI study participants in which pGCD59 was measured (reproduced from Ma et al (112), Fig. 3). [See this image and copyright information in PMC](https://pubmed.ncbi.nlm.nih.gov/42013312/) ## Similar articles * [ Plasma Glycated CD59 Predicts Early Gestational Diabetes and Large for Gestational Age Newborns. ](https://pubmed.ncbi.nlm.nih.gov/32069353/) Ma D, Luque-Fernandez MA, Bogdanet D, Desoye G, Dunne F, Halperin JA; DALI Core Investigator Group.Ma D, et al.J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1033-40. doi: 10.1210/clinem/dgaa087.J Clin Endocrinol Metab. 2020.PMID: 32069353Free PMC article.Clinical Trial. * [ Plasma-glycated CD59 as an early biomarker for gestational diabetes mellitus: prospective cohort study protocol. ](https://pubmed.ncbi.nlm.nih.gov/35443950/) Andrews C, Toth-Castillo M, Aktas H, Fernandez ML, Wong SK, Sen S, Halperin J.Andrews C, et al.BMJ Open. 2022 Apr 20;12(4):e054773. doi: 10.1136/bmjopen-2021-054773.BMJ Open. 2022.PMID: 35443950Free PMC article. * [ Plasma Glycated CD59 and Gestational Diabetes Mellitus: A Systematic Review. ](https://pubmed.ncbi.nlm.nih.gov/39548720/) Asadi Z, Safari-Faramani R, Aghaz F, Vaisi-Raygani A, Jalilian S.Asadi Z, et al.Endocrinol Diabetes Metab. 2024 Nov;7(6):e70013. doi: 10.1002/edm2.70013.Endocrinol Diabetes Metab. 2024.PMID: 39548720Free PMC article. * [ Plasma glycated CD59 (gCD59), a novel biomarker for the diagnosis, management and follow up of women with Gestational Diabetes (GDM) - protocol for prospective cohort study. ](https://pubmed.ncbi.nlm.nih.gov/32682411/) Bogdanet D, O'Shea PM, Halperin J, Dunne F.Bogdanet D, et al.BMC Pregnancy Childbirth. 2020 Jul 18;20(1):412. doi: 10.1186/s12884-020-03090-9.BMC Pregnancy Childbirth. 2020.PMID: 32682411Free PMC article. * [ Screening and diagnosing gestational diabetes mellitus. ](https://pubmed.ncbi.nlm.nih.gov/24423035/) Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Aktary WM, Pasichnyk D, Seida JC, Donovan L.Hartling L, et al.Evid Rep Technol Assess (Full Rep). 2012 Oct;(210):1-327.Evid Rep Technol Assess (Full Rep). 2012.PMID: 24423035Free PMC article.Review. [ See all similar articles ](https://pubmed.ncbi.nlm.nih.gov/?linkname=pubmed_pubmed&from_uid=42013312) ## References 1. 1. GBD 2021 Diabetes Collaborators . Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet. 2023;402(10397):203‐234. - [PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC10364581/) - [PubMed](https://pubmed.ncbi.nlm.nih.gov/37356446/) 2. 1. Parker ED, Lin J, Mahoney T, et al. Economic costs of diabetes in the U.S. in 2022. Diabetes Care. 2024;47(1):26‐43. - [PubMed](https://pubmed.ncbi.nlm.nih.gov/37909353/) 3. 1. McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019;5(1):47. - [PubMed](https://pubmed.ncbi.nlm.nih.gov/31296866/) 4. 1. Wexler DJ, Powe CE, Barbour LA, et al. Research gaps in gestational diabetes mellitu
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