Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial

项目总结 肥胖症和妊娠期糖尿病(GDM)的患病率都有所增加，而且两者都是相关的 有不良的围产期结果，包括胎儿过度生长，新生儿发病率，高血压疾病 怀孕和剖腹产。同时超重和肥胖的妊娠期糖尿病患者患糖尿病的几率更高。 妊娠并发症与患有妊娠期糖尿病的正常体重妇女相比，这可能部分是由于 血糖控制不佳。目前对患有糖尿病的孕妇的血糖指标的建议 糖尿病的定义不严格，远远超过空腹(70.9±7.8 mg/dL)和服药后1小时的平均水平 非妊娠期糖尿病孕妇餐后血糖值为(108.9±12.9)mg/dL。我们之前的工作证明了 与标准剂量(禁食95 mg/dL，餐后1小时，120 mg/dL)相比，强化使用(禁食90，餐后1小时 餐后高血糖指标140 mg/dL可改善血糖控制，而不增加风险 治疗低血糖。超重和肥胖妊娠期糖尿病妇女的强化血糖指标 糖尿病：多中心随机试验(IGDM试验)是一项大型、实用的随机临床试验，旨在 妊娠期糖尿病患者强化血糖指标与标准血糖指标对围产儿结局的影响 超重和肥胖的人。在5年的项目期间，来自4个国家的多学科调查小组 代表美国肥胖率高的地区的医疗中心将随机选择828名超重和 患有妊娠期糖尿病的肥胖女性可以选择强化或标准的血糖控制目标。 该项目的具体目标是：1)确定强化血糖目标在降低 超重和肥胖妇女新生儿综合发病率和胎龄儿出生体重大的风险 使用GDM，2)通过母体血糖升高的频率来评估强化血糖目标的安全性 妊娠期糖尿病超重和肥胖妇女的低血糖，以及3)评估强化治疗的成本-效果 血糖控制与标准血糖控制的比较，以每病例的增量成本衡量 预防和按质量调整的生命年的新生儿发病率和低出生体重。预期的结果 这项研究是关于强化降糖的有效性、安全性和成本效益的高质量证据。 减少患有妊娠期糖尿病的超重和肥胖妇女的不良围产期结局的目标。如果经过验证 有效，在患有妊娠期糖尿病的超重和肥胖女性中使用强化血糖靶点将有重要的意义 对这些高危妇女及其婴儿的健康产生积极影响。

PROJECT SUMMARY The prevalence of both obesity and gestational diabetes mellitus (GDM) have increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy, and cesarean delivery. Women with GDM who are also overweight and obese have higher rates of pregnancy complications when compared to normal weight women with GDM, which may occur in part due to suboptimal glycemic control. The current recommendations for glycemic targets in pregnant women with diabetes are not rigorously defined, and they far exceed the mean fasting (70.9 ±7.8 mg/dL) and 1 hour post- prandial (108.9 ± 12.9 mg/dL) glucose values in pregnant women without GDM. Our prior work demonstrated that use of intensive (fasting <90, 1 hr post-prandial <120 mg/dL) compared to standard (fasting <95 mg/dL, 1 hr post-prandial <140 mg/dL) glycemic targets resulted in improved glycemic control without increasing the risk for hypoglycemia. The Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial (iGDM Trial) is a large, pragmatic randomized clinical trial designed to investigate the impact of intensive versus standard glycemic 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 4 medical centers representing regions of the U.S. with high rates of obesity will randomize 828 overweight and obese women with GDM to either intensive or standard glycemic targets. The specific aims of this project are: 1) Determine the effectiveness of intensive glycemic targets in reducing the risk for neonatal composite morbidity and large for gestational age birthweight in overweight and obese women with GDM, 2) Assess the safety of intensive glycemic targets as measured by the frequency of maternal hypoglycemia in overweight and obese women with GDM, and 3) Evaluate the cost-effectiveness of intensive glycemic control compared with standard glycemic control as measured by the incremental cost per case of neonatal morbidity and LGA birth weight prevented and per Quality-adjusted Life-year. The expected outcome of this study is high-quality evidence on the effectiveness, safety, and cost-effectiveness of intensive glycemic targets in reducing adverse perinatal outcomes among overweight and obese women with GDM. If proven effective, use of intensive glycemic targets in overweight and obese women with GDM will have an important positive impact on the health of these high risk women and their infants.