A RANDOMIZED TREATMENT TRIAL OF MILD GESTATIONAL DIABETES

轻度妊娠糖尿病的随机治疗试验

• 批准号: 7376435
• 负责人: MICHAEL W. VARNER
• 金额: $ 0.93万
• 依托单位: UNIVERSITY OF UTAH
• 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 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376435
• 关键词: clinical trials; diet therapy; fasting; glucose; perinatal

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, a randomized clinical trial is proposed 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.

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。所列机构为中心机构，不一定为研究者机构。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。这项研究将比较随机接受饮食治疗的患者和随机接受无治疗的患者。被随机分配至无治疗组的患者与另一组未通过50 g葡萄糖筛查试验但未患妊娠期糖尿病的患者难以区分。这将最大限度地减少产科或医疗干预的混杂影响。还将入组非糖尿病对照组，其混杂变量与试验中的轻度妊娠糖尿病患者相匹配。