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

患有妊娠期糖尿病的超重和肥胖女性的强化血糖目标：一项多中心随机试验

• 批准号: 10399482
• 负责人: Christina Marie Scifres
• 金额: $ 64.12万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10399482
• 关键词: Birth Weight; Caring; Cesarean section; Clinical Trials; Clinical Trials Design; Data; Diabetes Mellitus; Effectiveness; Fasting; Fetal Growth; Fetal Macrosomia; Frequencies; Gestational Age; Gestational Diabetes; Glucose; Health; High Prevalence; High Risk Woman; Hour; Hypertension; Hypoglycemia; Incidence; Infant; Knowledge; Measures; Medical center; Morbidity - disease rate; Neonatal; Neonatal Hypoglycemia; Obesity; Outcome Study; Overweight; Perinatology; Pharmaceutical Preparations; Phototherapy; Pregnancy Complications; Pregnancy Outcome; Pregnancy Rate; Pregnant Women; Prevalence; Public Health; Quality-Adjusted Life Years; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Research; Research Personnel; Risk; Safety; Testing; Translating; Weight; Woman; Work; adverse maternal outcomes; adverse pregnancy outcome; clinical practice; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; effectiveness evaluation; glucose monitor; glycemic control; high risk; improved; maternal obesity; multidisciplinary; neonatal morbidity; neonatal outcome; offspring; perinatal complications; perinatal outcomes; pregnancy disorder; prevent; randomized trial; respiratory distress syndrome; safety and feasibility; standard care

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.

项目摘要 肥胖和妊娠期糖尿病（GDM）的患病率均有所增加，且两者均与妊娠期糖尿病（GDM）相关。 不良围产期结局，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。超重和肥胖的GDM女性有更高的 与正常体重的GDM女性相比，妊娠并发症可能部分由于以下原因而发生： 血糖控制欠佳。妊娠合并高血糖症孕妇血糖控制目标的当前建议 糖尿病没有严格的定义，他们远远超过平均空腹（70.9 ±7.8 mg/dL）和1小时后， 非GDM孕妇的餐时血糖值（108.9 ± 12.9 mg/dL）。我们之前的工作表明 使用强化（空腹<90，餐后1小时<120 mg/dL）与标准（空腹<95 mg/dL， h餐后<140 mg/dL）血糖目标导致血糖控制改善，而不增加风险 治疗低血糖超重和肥胖妇女合并糖尿病的强化血糖指标 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 研究强化与标准血糖目标对GDM妇女围产期结局的影响 超重和肥胖的人在为期5年的项目期间，来自4个国家的多学科调查人员组成了一个小组， 代表美国肥胖率高的地区的医疗中心将随机抽取828名超重和 GDM肥胖女性患者达到强化或标准血糖目标。 该项目的具体目标是：1）确定强化血糖目标在降低血糖水平方面的有效性。 超重和肥胖妇女的新生儿复合发病率和大于胎龄出生体重的风险 2）通过测量母体妊娠的频率，评估强化血糖目标的安全性， 超重和肥胖的GDM妇女的低血糖，3）评价强化治疗的成本效益 血糖控制与标准血糖控制相比，通过每例患者的增量成本来衡量， 预防的新生儿发病率和LGA出生体重以及每质量调整生命年。预期结果 这项研究的结果是关于强化血糖控制的有效性、安全性和成本效益的高质量证据。 在超重和肥胖的GDM妇女中降低不良围产期结局的目标。如果证明 在超重和肥胖的GDM妇女中有效地使用强化血糖目标， 对这些高危妇女及其婴儿的健康产生积极影响。