TREATMENT FOR MILD GESTATIONAL DIABETES MELLITUS

轻度妊娠糖尿病的治疗

• 批准号: 7377994
• 负责人: BRIAN M. MERCER
• 金额: $ 2.14万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377994
• 关键词: TREATMENT; MILD; GESTATIONAL; DIABETES; MELLITUS

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中得到体现。列出的机构是中心的机构，不一定是研究者的机构。妊娠糖尿病被定义为不同严重程度的碳水化合物不耐受，这是在怀孕期间首次发现的。无论是否使用胰岛素进行治疗或怀孕后病情是否持续，该定义均适用，并且不排除怀孕前可能患有未识别的糖尿病的可能性。众所周知，已有的糖尿病在很大程度上导致围产期发病率和死亡率。虽然母亲碳水化合物不耐受可能反映了不良后果的连续风险，但尚不清楚怀孕期间识别和随后治疗轻度碳水化合物不耐受是否有好处。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，以及是否有助于识别和治疗轻度疾病患者，建议对空腹血糖水平正常的妊娠糖尿病患者进行一项随机临床试验。该研究将比较随机接受饮食治疗的患者与随机接受不饮食治疗的患者。一个非糖尿病对照组，其 50 克葡萄糖测试异常，但根据传统的三小时口服葡萄糖耐量测试，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杂变量匹配。被随机分配不进行饮食治疗的患者将与非糖尿病对照组没有区别。这将最大限度地减少产科或医疗干预的混杂影响。所有患者都将接受标准的 3 小时 OGTT、分娩时采集的脐带血、通过足跟采集的婴儿血液以及新生儿人体测量。那些随机接受饮食治疗的女性还将每天进行四次血糖仪测试，直到分娩，并每周进行一次检查。