Comparison of two Screening Strategies for Gestational Diabetes
两种妊娠期糖尿病筛查策略的比较
基本信息
- 批准号:8935640
- 负责人:
- 金额:$ 53.91万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-09-25 至 2019-05-31
- 项目状态:已结题
- 来源:
- 关键词:AchievementAgeBeta CellBlindedBlood GlucoseBody Weight ChangesCardiovascular DiseasesCell physiologyChildChronic DiseaseConsensus Development ConferencesDataDecision MakingDetectionDiabetes MellitusDiagnosisDiagnosticDiagnostic ProcedureDyslipidemiasEarly identificationEnsureEnvironmentFastingFeasibility StudiesFetal GrowthFetusFrequenciesFunctional disorderFutureGestational AgeGestational DiabetesGlucoseGoalsGrowthGuidelinesHigh Risk WomanHourHyperglycemiaImpairmentInfantInflammationInsulin ResistanceInternationalLevel of EvidenceMetabolicMethodsMidwifeMonitorMothersNeonatalOGTTOne-Step dentin bonding systemOutcomeOutcome MeasureParticipantPatientsPerinatalPhysiciansPilot ProjectsPostpartum PeriodPregnancyPregnancy ComplicationsPregnancy OutcomePregnant WomenPrenatal carePreparationPrevalenceProtocols documentationProviderQuestionnairesRandomizedRandomized Controlled TrialsRecommendationResearchRiskSingle-Blind StudySiteTest ResultTestingTranslatingTreatment outcomeUnited States National Institutes of HealthWomanWomen&aposs Healthadverse outcomebaseclinical carecohortcomparative effectivenessdesigndiabetes riskdisorder riskeffectiveness trialexperiencefollow-upglucose metabolismimprovedin uteromeetingsmultidisciplinaryoffspringperinatal healthperinatal outcomespilot trialpreferenceprenatalpreventprimary outcomepublic health relevancescreeningsecondary outcome
项目摘要
DESCRIPTION (provided by applicant): Impaired glucose metabolism (gestational diabetes (GDM) and mild hyperglycemia) that occurs during pregnancy is associated with an increased risk for pregnancy complications and is also an early indication of long- term metabolic dysfunction leading to diabetes and cardiovascular disease. In the US, GDM is commonly diagnosed using a two-step screening and diagnostic approach. The International Association of Diabetes and Pregnancy Study Group (IADPSG) proposed a one-step diagnostic approach that broadens the definition of GDM by lowering the cutoff values to include women with milder forms of hyperglycemia, who would have screened normal under the current two-step approach. The goal of these recommendations is better identification of women at risk for pregnancy complications and long-term metabolic dysfunction, but it results in a significant increase in the prevalence of GDM. The NIH Gestational Diabetes Consensus Development Conference committee does not recommend changing from the current two-step screening/diagnostic approach to the IADPSG one-step diagnostic approach without trials demonstrating that increasing the number of women diagnosed as having GDM results in better outcomes. In this application, we aim to 1) conduct a "real world" randomized controlled trial (RCT) to determine differences in short-term perinatal health outcomes with GDM testing between the two predominant GDM screening approaches, and 2) prospectively follow the mothers to examine their metabolic risk profiles and the growth of their infants at one year postpartum. Based on a pilot feasibility study, we propose a single site blinded RCT of 920 pregnant women at 18-24 weeks' gestation between ages 18-45 years who have not been diagnosed with diabetes, with a singleton pregnancy. Participants will have a non-fasting 1 hour 50 gm glucose challenge test (GCT) performed between 24-28 weeks' gestation. Women with 50 gm GCT results < 200 mg/dL will be randomized to receive either a fasting 2 hour 75 gm oral glucose tolerance test (OGTT) or a 3 hour 100 gm OGTT. GDM will be diagnosed using the IADPSG criteria for women receiving the 75 gm OGTT and Carpenter-Coustan criteria for women receiving the 100 gm. Participants and their physicians will be informed of the diagnosis of GDM, but will be blinded to the specific test results and criteria used to make the diagnosis. Participants with GDM will receive treatment as determined by their primary physician or midwife, and all participants will continue routine prenatal care. Brief questionnaires will be used to assess participants' and physicians' views on GDM testing. Metabolic profiles for participants will be assessed at randomization and at a year postpartum. The primary outcome measure is large-for-gestational age fetal growth. The rationale for the proposed research is that this is a unique opportunity to compare the two methods. At the end of the study, we will know whether women diagnosed at lower glucose levels with the IADPSG criteria are more likely to have adverse perinatal outcomes. It is our hypothesis that using IADPSG diagnostic criteria will result in detection of more women with impaired glucose metabolism and that treating these women will reduce adverse perinatal outcomes and prevent long-term metabolic dysfunction. This study will provide data grounded in level A evidence, to evaluate the two screening methods so universal guidelines for GDM screening can be endorsed by major organizations and implemented into clinical care.
描述(由申请人提供):怀孕期间发生的葡萄糖代谢受损(妊娠糖尿病(GDM)和轻度高血糖)与妊娠并发症风险增加相关,也是导致糖尿病和心血管疾病的长期代谢功能障碍的早期迹象。疾病。在美国,GDM 通常采用两步筛查和诊断方法进行诊断。国际糖尿病和妊娠研究协会 (IADPSG) 提出了一种一步诊断方法,通过降低临界值来扩大 GDM 的定义,将患有轻度高血糖的女性纳入其中,而在目前的两步诊断方法下,这些女性可能会被筛查为正常。方法。这些建议的目标是更好地识别有妊娠并发症和长期代谢功能障碍风险的女性,但这会导致 GDM 患病率显着增加。如果没有试验证明增加诊断为 GDM 的女性数量会带来更好的结果,NIH 妊娠糖尿病共识发展会议委员会不建议从当前的两步筛查/诊断方法更改为 IADPSG 一步诊断方法。在此应用中,我们的目标是 1) 进行“真实世界”随机对照试验 (RCT),以确定两种主要 GDM 筛查方法之间通过 GDM 检测的短期围产期健康结果的差异,以及 2) 前瞻性地跟踪母亲检查她们的代谢风险状况以及产后一年婴儿的生长情况。根据一项试点可行性研究,我们建议对 920 名年龄在 18-45 岁之间、未诊断出患有糖尿病、妊娠 18-24 周、单胎妊娠的孕妇进行单中心盲法随机对照试验。参与者将在妊娠 24-28 周期间进行非空腹 1 小时 50 克葡萄糖激发试验 (GCT)。 50 gm GCT 结果 < 200 mg/dL 的女性将随机接受空腹 2 小时 75 gm 口服葡萄糖耐量试验 (OGTT) 或 3 小时 100 gm OGTT。对于接受 75 克 OGTT 的女性,将使用 IADPSG 标准进行诊断;对于接受 100 克 OGTT 的女性,将使用 Carpenter-Coustan 标准进行 GDM 诊断。参与者及其医生将被告知 GDM 的诊断,但不会了解用于诊断的具体测试结果和标准。 GDM 参与者将接受其主治医生或助产士确定的治疗,所有参与者将继续常规产前护理。将使用简短的调查问卷来评估参与者和医生对 GDM 测试的看法。参与者的代谢特征将在随机分组和产后一年进行评估。主要结局指标是大于胎龄胎儿的生长情况。拟议研究的理由是,这是比较这两种方法的独特机会。在研究结束时,我们将知道根据 IADPSG 标准诊断出血糖水平较低的女性是否更有可能出现不良围产期结局。我们的假设是,使用 IADPSG 诊断标准将导致检测出更多葡萄糖代谢受损的女性,并且治疗这些女性将减少不良的围产期结局并预防长期代谢功能障碍。这项研究将提供基于 A 级证据的数据,以评估两种筛查方法,以便 GDM 筛查的通用指南能够得到主要组织的认可并实施到临床护理中。
项目成果
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{{ truncateString('ESA M DAVIS', 18)}}的其他基金
TRANSforming Bio-medical Research & Academic Faculty through Opportunity, TRaining, & Mentorship (TRANSFORM)
转变生物医学研究
- 批准号:
10472689 - 财政年份:2021
- 资助金额:
$ 53.91万 - 项目类别:
TRANSforming Bio-medical Research & Academic Faculty through Opportunity, TRaining, & Mentorship (TRANSFORM)
转变生物医学研究
- 批准号:
10284463 - 财政年份:2021
- 资助金额:
$ 53.91万 - 项目类别:
TRANSforming Bio-medical Research & Academic Faculty through Opportunity, TRaining, & Mentorship (TRANSFORM)
转变生物医学研究
- 批准号:
10675028 - 财政年份:2021
- 资助金额:
$ 53.91万 - 项目类别:
Comparison of two Screening Strategies for Gestational Diabetes
两种妊娠期糖尿病筛查策略的比较
- 批准号:
9069462 - 财政年份:2014
- 资助金额:
$ 53.91万 - 项目类别:
Comparison of two Screening Strategies for Gestational Diabetes
两种妊娠期糖尿病筛查策略的比较
- 批准号:
8816704 - 财政年份:2014
- 资助金额:
$ 53.91万 - 项目类别:
Comparison of two Screening Strategies for Gestational Diabetes
两种妊娠期糖尿病筛查策略的比较
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9275506 - 财政年份:2014
- 资助金额:
$ 53.91万 - 项目类别:
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