Divisions of Hematology, Brigham & Women's Hospital, Boston, Massachusetts.
Department of Epidemiology, Harvard T.H. Chan School of Public Health. Boston, Massachusetts.
J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1033-40. doi: 10.1210/clinem/dgaa087.
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.
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.
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.
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).
Our results indicate that pGCD59 is a simple and accurate biomarker for detection of GDM in early pregnancy and risk assessment of LGA.
在孕早期诊断出的妊娠糖尿病（GDM）是一个医疗保健挑战，因为它会增加不良结局的风险。血浆糖化 CD59（pGCD59）是一种新兴的糖尿病和 GDM 生物标志物。本研究旨在评估 pGCD59 作为早期 GDM 生物标志物的性能及其与分娩巨大儿（LGA）的关系。
评估 pGCD59 识别孕早期 GDM 女性（GDM<20）的性能，并评估 pGCD59 与 LGA 以及与 GDM 相关的其他潜在不良新生儿结局的关系。
在维生素 D 和生活方式干预研究中，对 693 名肥胖女性（BMI>29）进行了 75g、2 小时口服葡萄糖耐量试验（OGTT），这些女性在<20 周妊娠时进行了 75g、2 小时 OGTT，主要分析包括 486 名在整个孕期糖耐量正常的受试者、207 名在<20 周时符合 GDM 标准的受试者和 77 名在 24-28 周妊娠时被诊断为 GDM 的受试者。参考试验为基于国际糖尿病与妊娠研究组标准的 75g、2 小时 OGTT 裁决。指数试验是一种 pGCD59 ELISA。
在 GDM<20 的女性中，pGCD59 水平明显更高（P<0.001）（3.9±1.1 标准肽单位 [SPU]），而在无 GDM 的女性中则较低（2.7±0.7 SPU）。pGCD59 可准确识别早孕期 GDM，曲线下面积（AUC）的受试者工作特征曲线为 0.86（95%置信区间 [CI]，0.83-0.90）。母体 pGCD59 水平每增加 1 个单位，分娩 LGA 婴儿的几率就会增加 36%（LGA 与非 LGA 婴儿的比值比：1.4；95%CI，1.1-1.8；P=0.016）。
我们的研究结果表明，pGCD59 是一种简单而准确的生物标志物，可用于早期妊娠 GDM 的检测和 LGA 的风险评估。
