Obstetric-Fetal Pharmacology Research Units Network

产科-胎儿药理学研究单位网络

• 批准号: 7942483
• 负责人: GARY D HANKINS
• 金额: $ 23.5万
• 依托单位: UNIVERSITY OF TEXAS MED BR GALVESTON
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2010-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7942483
• 关键词: Aneuploidy; Animal Model; Area; Aromatase; Blood Vessels; Caring; Chronic; Clinic; Clinical; Clinical Trials; Data; Diabetes Mellitus; Discipline of obstetrics; Doctor of Philosophy; Drug Kinetics; Enzymes; Evaluation; Evaluation Studies; Funding; Genetic Polymorphism; Head; Human; Human Chorionic Gonadotropin; Hypoglycemic Agents; In Vitro; Infection; Investigation; Laboratories; Ligands; Lobule; Magnesium Sulfate; Maternal Physiology; Maternal and Child Health; Mediating; Medical; Metabolic; Modeling; Multicenter Trials; Neonatal; Neonatology; Opiates; Outcome; Papio; Patient Recruitments; Perfusion; Pharmaceutical Preparations; Pharmacology; Physiology; Placenta; Population; Pregnancy; Pregnancy Proteins; Pregnant Women; Preparation; Primates; Protocols documentation; Research; Research Personnel; Risk; Scientist; Second Pregnancy Trimester; System; Texas; Tissues; Ultrasonography; United States National Institutes of Health; Universities; Vagina; diabetic; experience; fetal; fetal medicine; in vivo; member; placental transfer; programs; protocol development; receptor; response; trophoblast

DESCRIPTION (provided by applicant): The University of Texas Medical Branch (UTMB) has the capability to participate actively as a member of the Obstetric-Fetal Pharmacology Research Units (OPRU) Network. Gary Hankins, MD, as PI, is responsible for the proposed clinical trial on the use of hypoglycemic drugs in the treatment of diabetes during pregnancy. He has extensive experience within several NIH multicenter trials, eg, First and Second Trimester Evaluation of Risk of Aneuploidy (FASTER), Beneficial Effects of Antenatal Magnesium Sulfate Study (BEAM), and the Vaginal Ultrasound Cerclage Trial. Dr. Hankins has achieved successful patient recruitment and retention by involvement with UTMB's Regional Maternal & Child Health Program (RMCHP). All RMCHP clinics follow protocols established by the Maternal-Fetal Medicine division, headed by Dr. Hankins. Over 12,000 pregnant women are cared for annually within the RMCHP clinic system, approximately 7,000 of whom deliver at UTMB. The Pharmacology/Pharmacokinetics (PK) Co-Investigator, Mahmoud S. Ahmed, PhD, has over 25 years of expertise in utilizing human placenta and derived preparations in his investigations. Dr. Ahmed is a laboratory-pioneered investigator in placental receptors, their natural ligands and mediated responses, as well as the mechanism of hCG release from trophoblast tissue. They investigated the effects of in vitro and in vivo chronic administration of opiates on placental physiology and maternal-neonatal outcome. Utilizing dual perfusion of placental lobule, they demonstrated the influence of efflux protein and placental metabolic [enzymes on the PK for placental transfer of opiates. They identified placental aromatase as a drug-metabolizing enzyme and are investigating its polymorphism. Kenneth D. Carey, DVM, PhD, as Animal Model Co-Investigator, is responsible for coordinating the baboon studies to be conducted at the Southwest National Primate Research Center (SNPRC) in San Antonio. A population of normal and diabetic baboons will be studied. Dr. Hankins is an adjunct investigator at the SNPRC and has had extensive involvement with the Primate research staff. The Department of Ob/Gyn has well-funded scientists with expertise in areas relevant to this RFA including infection, vascular physiology, and placental functions. Clinical PK Co-Investigators Susan Abdel-Rahman, Pharm D., and Wayne Snodgrass, MD, PhD, have over 30 years of combined experience in the development of protocols for PK studies, evaluation of data obtained, and PK/PD modeling. The Division of Neonatology, the GCRC, and other departments at UTMB will provide support for this project.

描述（由申请人提供）：德克萨斯大学医学分支机构（UTMB）有能力积极参与作为产科 - 狂热药理学研究单位（OPRU）网络的成员。医学博士Gary Hankins作为PI，负责拟议的临床试验，该试验在怀孕期间使用降血糖药物治疗糖尿病。他在几项NIH多中心试验中拥有丰富的经验，例如，孕产生硫酸镁研究（BEAM）和阴道超声CERCLAGE试验的非整倍性风险（更快），有益的效果。 Hankins博士通过参与UTMB的区域孕产妇健康计划（RMCHP）实现了成功的患者招聘和保留。所有RMCHP诊所均遵循由汉金斯博士领导的母亲 - 福利医学部建立的方案。每年在RMCHP诊所系统中每年都有12,000多名孕妇的照顾，其中约有7,000名在UTMB交付。药理学/药代动力学（PK）共同投资者Mahmoud S. Ahmed博士在他的调查中使用人体胎盘和衍生准备工作有25年以上的专业知识。艾哈迈德（Ahmed）博士是胎盘受体，天然配体和介导的反应以及HCG从滋养细胞组织中释放的机制的实验室偏位研究者。他们调查了鸦片剂的体外和体内长期给药对胎盘生理和孕产妇 - 神经结局的影响。利用胎盘小叶的双重灌注，他们证明了外排蛋白和胎盘代谢[PK上的酶以用于胎盘转移阿片类药物的影响。他们将胎盘芳香酶确定为一种药物代谢酶，并正在研究其多态性。肯尼斯·凯里（Kenneth D.将研究正常和糖尿病狒狒的人群。 Hankins博士是SNPRC的兼职调查员，并且与灵长类动物研究人员大量参与。 OB/GYN系拥有与该RFA有关的领域的专业知识，包括感染，血管生理和胎盘功能。临床PK共同研究人员Susan Abdel-Rahman，Pharm D.和MD，PhD的Wayne Snodgrass在PK研究方案，获得的数据评估以及PK/PD建模方面拥有30多年的综合经验。 Neonatology，GCRC和UTMB的其他部门的部门将为该项目提供支持。