TREATMENT FOR MILD GESTATIONAL DIABETES MELLITUS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。妊娠期糖尿病被定义为不同程度的碳水化合物不耐受，在妊娠期间首次被发现。这一定义适用于不论是否使用胰岛素治疗或妊娠后病情是否持续，也不排除妊娠前可能存在未被发现的糖尿病的可能性。众所周知，预先存在的糖尿病在很大程度上导致了围产期发病率和死亡率。虽然母体碳水化合物不耐受可能反映了不良后果的连续性风险，但尚不清楚孕期轻度碳水化合物不耐受的识别和后续治疗是否有益。为了确定轻度妊娠糖尿病是否是不良围产期结局的危险因素，以及在识别和治疗轻度疾病患者方面是否有实用价值，提出了一项随机临床试验，研究对象是空腹血糖水平正常的妊娠糖尿病患者。这项研究将比较随机接受饮食治疗的患者和随机接受不接受饮食治疗的患者。非糖尿病对照组，50克葡萄糖试验异常，但根据传统的3小时口服葡萄糖耐量试验没有妊娠糖尿病，将与试验中的轻度妊娠糖尿病患者进行混淆变量匹配。被随机分配到无饮食治疗组的患者将与非糖尿病对照组区分开来。这将最大限度地减少产科或医疗干预的混杂影响。所有患者将接受标准的3小时OGTT，分娩时采集脐带血，通过鞋跟和新生儿人体测量测量采集婴儿血液。那些随机接受饮食治疗的妇女还将每天进行四次血糖仪检测，直到分娩，每周检查一次。

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 is defined as carbohydrates intolerance of variable severity, which is first recognized during pregnancy. This definition applies regardless of insulin use for treatment or persistence of the condition after pregnancy, and does not exclude the possibility that unrecognized diabetes may have preceded the pregnancy. It is known that pre-existing diabetes substantially contributes to perinatal morbidity and mortality. 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. 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 of patients with gestational diabetes who have normal fasting glucose level. The study will compare patients who have been randomized to diet therapy with patients who have been randomized to no diet therapy. A non-diabetic control group, who have an abnormal 50 gram glucose test but do not have gestational diabetes based on a traditional three hour oral glucose tolerance test, will be matched for confounding variables with the mild gestational diabetic patients in the trial. Patients who have been randomized to no dietary treatment will be indistinguished from the non-diabetic control group. This will minimize the confounding influence of obstetrical or medical intervention. All patients will undergo a standard 3-hour OGTT, umbilical cord blood obtained at delivery, infant blood obtained via heelstick and neonatal anthropometric measurements. Those women randomized to diet therapy will also perform glucometer testing four times daily until delivery and be seen weekly.