A RANDOMIZED CLINICAL TRIAL OF TREATMENT FOR GESTATIONAL DIABETES MELLITUS

妊娠糖尿病治疗的随机临床试验

• 批准号: 7376854
• 负责人: ALAN M PEACEMAN
• 金额: $ 0.89万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376854
• 关键词: RANDOMIZED; CLINICAL; TRIAL; TREATMENT; GESTATIONAL

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).

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。妊娠期糖尿病（GDM）是指在妊娠期间发病或首次发现的各种严重程度的碳水化合物不耐受。无论是否使用胰岛素治疗，或妊娠后病情是否持续，该定义均适用，并且不排除未识别的葡萄糖耐受不良或明显糖尿病可能在妊娠前发生的可能性。众所周知，预先存在的糖尿病大大有助于围产期发病率和死亡率。人们也普遍认为，空腹血糖水平显著升高的妊娠期糖尿病患者出现宫内胎儿死亡的风险增加。然而，这只代表了妊娠糖尿病患者的一小部分，妊娠糖尿病患者约占所有妊娠的2%至3%。轻度妊娠期糖尿病与不良妊娠结局（包括巨大儿、产伤和新生儿低血糖症等发病率）的相关性仍然值得怀疑，因为这种情况经常与其他风险因素（如种族、母亲肥胖、年龄和产次）混淆。虽然母体碳水化合物不耐受可能反映了不良结局的连续风险，但尚不清楚妊娠期间轻度碳水化合物不耐受的识别和后续治疗是否有益。随着根据第四届GDM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，本试验将描述治疗导致发病率降低的血糖异常水平。 为了确定轻度妊娠期糖尿病是否是不良围产期结局的危险因素，以及是否有在识别和治疗轻度疾病患者的效用，建议对空腹血糖水平正常的患者进行随机临床试验。该研究将比较随机接受饮食治疗（第I组）的轻度妊娠糖尿病患者与随机接受无治疗（第IIA组）的患者。