A RANDOMIZED CLINICAL TRIAL OF TREATMENT FOR GESTATIONAL DIABETES MELLITUS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。妊娠期糖尿病(GDM)被定义为在妊娠期起病或首次识别的不同严重程度的碳水化合物不耐受。这一定义适用于无论是否使用胰岛素进行治疗，或怀孕后病情是否持续，也不排除未识别的葡萄糖耐量异常或显性糖尿病可能在怀孕前就已存在的可能性。众所周知，既往糖尿病对围产期发病率和死亡率有很大影响。人们还普遍认为，妊娠期糖尿病患者如果空腹血糖水平显著升高，胎儿宫内死亡的风险似乎会增加。然而，这只占妊娠期糖尿病患者的一小部分，妊娠期糖尿病患者的并发症约占所有妊娠的2%至3%。轻度妊娠期糖尿病与不良妊娠结局的关联仍然值得怀疑，因为这种情况往往与种族、母亲肥胖、年龄和产次等其他风险因素混淆。虽然母亲碳水化合物不耐受很可能反映了不良后果的连续风险，但尚不清楚在妊娠期识别和随后治疗轻度碳水化合物不耐受是否有益。随着根据第四次全球可持续发展问题国际研讨会的建议进一步降低诊断门槛，这个问题变得更加重要。此外，该试验将描述血糖异常的水平，在这种情况下，治疗会降低发病率。为了确定轻度妊娠期糖尿病是否是不良围产儿结局的危险因素，以及在识别和治疗轻度疾病患者方面是否有效，建议对空腹血糖水平正常的患者进行随机临床试验。这项研究将比较随机接受饮食治疗的轻度妊娠期糖尿病患者(I组)和随机接受不治疗的患者(IIA组)。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Gestational diabetes mellitus (GDM) is defined as carbohydrate intolerance of variable severity with onset or first recognition during pregnancy. The definition applies regardless of insulin use for treatment, or the persistence of the condition after pregnancy, and does not exclude the possibility that unrecognized glucose intolerance or overt diabetes may have preceded the pregnancy. It is known that pre-existing diabetes substantially contributes to perinatal morbidity and mortality. It is also generally agreed that patients with gestational diabetes who have significantly elevated fasting blood glucose levels appear to have an increased risk of intrauterine fetal death. However, this represents a small fraction of patients with gestational diabetes, which complicates about two to three percent of all pregnancies. The association of milder forms of gestational diabetes with adverse pregnancy outcome including morbidities such as macrosomia, birth trauma and neonatal hypoglycemia, remains questionable, because the condition is often confounded with other risk factors such as race, maternal obesity, age and parity. While it is likely that maternal carbohydrate intolerance reflects a continuum of risk for adverse outcomes, it is not known whether there is a benefit to identification and subsequent treatment of mild carbohydrate intolerance during pregnancy. This question has assumed greater importance with further lowering of the thresholds for diagnosis based on recommendations of the Fourth International Workshop Conference on GDM. Further, the trial will characterize the level of glucose abnormality where treatment results in decreased morbidity. To determine whether mild gestational diabetes is a risk factor for adverse perinatal outcome and whether there is utility in identifying and treating patients with mild disease, a randomized clinical trial is proposed for patients with a normal fasting glucose level. The study will compare patients with mild gestational diabetes who have been randomized to diet therapy (Group I) with patients who have been randomized to no treatment (Group IIA).