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.
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