Plasma Glycated CD59 Predicts Early Gestational Diabetes and Large for Gestational Age Newborns

J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1033-e1040. doi: 10.1210/clinem/dgaa087.


Context: Gestational diabetes mellitus (GDM) diagnosed in early pregnancy is a health care challenge because it increases the risk of adverse outcomes. Plasma-glycated CD59 (pGCD59) is an emerging biomarker for diabetes and GDM. The aim of this study was to assess the performance of pGCD59 as a biomarker of early GDM and its association with delivering a large for gestational age (LGA) infant.

Objectives: To assess the performance of pGCD59 to identify women with GDM in early pregnancy (GDM < 20) and assess the association of pGCD59 with LGA and potentially others adverse neonatal outcomes linked to GDM.

Methods: Blood levels of pGCD59 were measured in samples from 693 obese women (body mass index > 29) undergoing a 75-g, 2-hour oral glucose tolerance test (OGTT) at <20 weeks' gestation in the Vitamin D and Lifestyle Intervention study: the main analyses included 486 subjects who had normal glucose tolerance throughout the pregnancy, 207 who met criteria for GDM at <20 weeks, and 77 diagnosed with GDM at pregnancy weeks 24 through 28. Reference tests were 75-g, 2-hour OGTT adjudicated based on International Association of Diabetes and Pregnancy Study Group criteria. The index test was a pGCD59 ELISA.

Results: Mean pGCD59 levels were significantly higher (P < 0.001) in women with GDM < 20 (3.9 ± 1.1 standard peptide units [SPU]) than in those without (2.7 ± 0.7 SPU). pGCD59 accurately identified GDM in early pregnancy with an area under the curve receiver operating characteristic curves of 0.86 (95% confidence interval [CI], 0.83-0.90). One-unit increase in maternal pGCD59 level was associated with 36% increased odds of delivering an LGA infant (odds ratio for LGA vs non-LGA infant: 1.4; 95% CI, 1.1-1.8; P = 0.016).

Conclusion: Our results indicate that pGCD59 is a simple and accurate biomarker for detection of GDM in early pregnancy and risk assessment of LGA.

Keywords: biomarkers; epidemiology; gestational diabetes mellitus; glycation; prediction.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biomarkers / blood*
  • Blood Glucose / analysis
  • CD59 Antigens / blood*
  • Diabetes, Gestational / blood
  • Diabetes, Gestational / diagnosis*
  • Diabetes, Gestational / epidemiology
  • Female
  • Fetal Macrosomia / blood
  • Fetal Macrosomia / diagnosis*
  • Fetal Macrosomia / epidemiology
  • Follow-Up Studies
  • Gestational Age
  • Glycosylation
  • Humans
  • Infant, Newborn
  • Infant, Newborn, Diseases / blood
  • Infant, Newborn, Diseases / diagnosis*
  • Infant, Newborn, Diseases / epidemiology
  • Pregnancy
  • Pregnancy Complications / blood
  • Pregnancy Complications / diagnosis*
  • Pregnancy Complications / epidemiology
  • Prognosis
  • Risk Factors
  • Young Adult


  • Biomarkers
  • Blood Glucose
  • CD59 Antigens
  • CD59 protein, human

Associated data

  • ISRCTN/ISRCTN70595832