PK AND PD OF GLYBURIDE

格列本脲的 PK 和 PD

• 批准号: 7376159
• 负责人: MENACHEM MIODOVNIK
• 金额: $ 0.31万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376159
• 关键词: PK; PD; GLYBURIDE

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 (GDM) complicates ~4% of all pregnancies in the United States. GDM resembles type 2 diabetes mellitus. Infants born to mothers with GDM are at risk for stillbirth, macrosomia (associated birth injuries), hydramnios and neonatal metabolic complications (e.g. hypoglycemia, insulin resistance, hyperinsulinemia). Mothers are at risk for infections, hypertension, preeclampsia and diabetic ketoacidosis. Tight glucose control reduces risks for mothers and their babies but can be associated with maternal hypoglycemia. Glyburide (GLY) have been used during pregnancy for treatment of GDM however very little is known about the pharmacokinetics (PK) and pharmacodynamics (PD) of this agent during pregnancy. This study will evaluate the PK and PD of GLY during pregnancy as compared to recently diagnosed, matched, type 2 diabetic controls. The hypothesis is that the pharmacokinetics and pharmacodynamics of glyburide are altered during pregnancy. The specific aim is:To determine the pharmacokinetics and pharmacodynamics of glyburide during the third trimester of pregnancy as compared to recently diagnosed, matched, type 2 diabetes mellitus patients.

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，不一定是研究者所在机构。在美国，妊娠期糖尿病（GDM）的并发症约占所有妊娠的4%。GDM与2型糖尿病相似。患有GDM的母亲所生的婴儿有死产、巨大儿（相关产伤）、羊水过多和新生儿代谢并发症（如低血糖、胰岛素抵抗、高胰岛素血症）的风险。母亲有感染、高血压、先兆子痫和糖尿病酮症酸中毒的风险。严格的血糖控制降低了母亲和婴儿的风险，但可能与母亲低血糖有关。妊娠期间使用格列本脲（GLY）治疗GDM，但对妊娠期间该药的药代动力学（PK）和药效学（PD）知之甚少。本研究将评价妊娠期间GLY的PK和PD，并与最近诊断的匹配2型糖尿病对照进行比较。假设妊娠期间格列本脲的药代动力学和药效学发生改变。具体目的是：确定妊娠晚期格列本脲的药代动力学和药效学，与最近诊断的匹配的2型糖尿病患者进行比较。