Indiana University School of Medicine, Indianapolis, Indiana, USA
The University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, USA.
BMJ Open. 2024 Feb 29;14(2):e082126. doi: 10.1136/bmjopen-2023-082126.
The prevalence of both obesity and gestational diabetes mellitus (GDM) has increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy and caesarean delivery. Women with GDM who are also overweight or obese have higher rates of pregnancy complications when compared with normal-weight women with GDM, which may occur in part due to suboptimal glycaemic control. The current recommendations for glycaemic targets in pregnant women with diabetes are based on limited evidence and exceed the mean fasting (70.9±7.8 mg/dL) and 1-hour postprandial (108.9±12.9 mg/dL) glucose values in pregnant individuals without diabetes. Our prior work demonstrated that the use of intensive (fasting <90 mg/dL and 1-hour postprandial <120 mg/dL) compared with standard (fasting <95 mg/dL and 1-hour postprandial <140 mg/dL) glycaemic targets resulted in improved glycaemic control without increasing the risk for hypoglycaemia in pregnant individuals with GDM, but the impact of intensive glycaemic targets on perinatal outcomes is unknown.
The Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial (iGDM Trial) is a large, pragmatic randomised clinical trial designed to investigate the impact of intensive versus standard glycaemic targets on perinatal outcomes in women with GDM who are overweight and obese. During the 5-year project period, a multidisciplinary team of investigators from five medical centres representing regions of the USA with high rates of obesity will randomise 828 overweight and obese women with GDM to either intensive or standard glycaemic targets. We will test the central hypothesis that intensive glycaemic targets will result in lower rates of neonatal composite morbidity including large for gestational age birth weight, neonatal hypoglycaemia, respiratory distress syndrome and need for phototherapy when compared with standard glycaemic targets using the intention-to-treat approach to analysis.
The Institutional Review Board (IRB) at Indiana University School of Medicine approved this study (IRB# 11435; initial approval date 25 August 2021). We will submit the results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings.
NCT05124808.
肥胖和妊娠糖尿病（GDM）的患病率都有所增加，两者都与不良围产期结局相关，包括胎儿过度生长、新生儿发病率、妊娠高血压疾病和剖宫产。与正常体重的 GDM 妇女相比，超重或肥胖的 GDM 妇女妊娠并发症的发生率更高，这可能部分是由于血糖控制不佳。目前针对糖尿病孕妇血糖目标的建议是基于有限的证据得出的，超过了无糖尿病孕妇的空腹（70.9±7.8mg/dL）和 1 小时餐后（108.9±12.9mg/dL）血糖值。我们之前的研究表明，与标准（空腹<95mg/dL 和 1 小时餐后<140mg/dL）相比，使用强化（空腹<90mg/dL 和 1 小时餐后<120mg/dL）血糖目标可改善血糖控制，而不会增加 GDM 孕妇低血糖的风险，但强化血糖目标对围产期结局的影响尚不清楚。
超重和肥胖的妊娠糖尿病患者强化血糖目标：一项多中心随机试验（iGDM 试验）是一项大型实用随机临床试验，旨在研究强化与标准血糖目标对超重和肥胖的 GDM 妇女围产期结局的影响。在为期 5 年的项目期间，来自代表美国肥胖率较高地区的五个医疗中心的多学科研究人员团队将对 828 名超重和肥胖的 GDM 妇女进行随机分组，接受强化或标准血糖目标治疗。我们将通过意向治疗分析方法检验主要假设，即与标准血糖目标相比，强化血糖目标将降低新生儿复合发病率的发生率，包括巨大儿出生体重、新生儿低血糖、呼吸窘迫综合征和需要光疗。
印第安纳大学医学院的机构审查委员会（IRB）批准了这项研究（IRB#11435；最初批准日期 2021 年 8 月 25 日）。我们将提交试验结果在同行评议期刊上发表，并在国际科学会议上进行演示。
NCT05124808。
