CLINICAL TRIAL: A RANDOMIZED TREATMENT TRIAL OF MILD GESTATIONAL DIABETES

临床试验：轻度妊娠糖尿病的随机治疗试验

• 批准号: 7718496
• 负责人: MICHAEL W. VARNER
• 金额: $ 0.89万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-03-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7718496
• 关键词: Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Confounding Factors (Epidemiology); Control Groups; Diet therapy; Disease; Enrollment; Fasting; Funding; Gestational Diabetes; Glucose; Grant; Institution; Intervention; Medical; Outcome; Patients; Perinatal; Randomized; Research; Research Personnel; Resources; Risk Factors; Screening procedure; Source; Testing; United States National Institutes of Health; diabetic; non-diabetic; treatment trial

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. 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, we are conducting a clinical trial of patients with a normal fasting glucose level. The study will compare patients who have been randomized to diet therapy with patients who have been randomized to no treatment. Patients who have been randomized to no treatment will be indistinguishable from another enrolled group of patients who have failed the 50-gram glucose screening test but who do not have gestational diabetes. This will minimize the confounding influence of obstetrical or medical interventions. A non-diabetic control group, matched for confounding variables with the mild gestational diabetic patients in the trial, will also be enrolled.

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 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，以及在识别和治疗轻度疾病患者方面是否有效，我们正在对空腹血糖水平正常的患者进行临床试验。这项研究将对随机接受饮食治疗的患者和随机接受不治疗的患者进行比较。被随机分成不接受治疗的患者与另一组没有通过50克葡萄糖筛查测试但没有患有妊娠期糖尿病的患者没有什么区别。这将最大限度地减少产科或医疗干预的混杂影响。在试验中，与轻度妊娠期糖尿病患者的混淆变量匹配的非糖尿病对照组也将被纳入。