Clinical and Translational Core
The overall objective of the Clinical and Translational (C&T) Core is to provide innovative technologies and services for Center investigators to generate new knowledge that can be translated into effective, high impact diagnostic and therapeutic applications for the prevention and treatment of kidney disease and its complications, particularly cardiovascular disease.
The Core accomplishes this objective by:
- Directly supporting the overall goal of the UTSW George M. O’Brien Jr. Kidney Center to promote bidirectional collaborative interactions between basic and clinical researchers that will fundamentally advance our understanding of kidney development and pathophysiology and yield more effective treatments for kidney disease and its complications.
- Providing the critical infrastructure needed to conduct funded projects in clinical and translational nephrology research that facilitate understanding of disease mechanisms spanning the spectrum of translational research.
- Interacting with other George M. O’Brien Jr. Cores to accomplish the objectives, including: a) the Cell Biology Core on discovery of kidney disease markers (i.e. Klotho in humans) and novel imaging techniques (MRI) for development of clinical trials; b) the Physiology Core on discovery of mechanisms of hypertension; and c) the Animal Core on mechanisms of Chronic Kidney Disease (CKD) development and progression.
- Providing experienced research personnel, including biostatisticians, research nurses, study drug dispensation services, and coordinators with expertise in clinical and translational kidney and cardiovascular disease research to enhances the implementation of research studies ranging from early to later stage translational and patient-oriented research, including diagnostic, mechanistic, genetic, interventional and epidemiologic research.
- Serving as a training vehicle for early investigators to increase the declining nephrology research workforce.
The Clinical and Translational Core also provides state-of-the-art phenotypic measurements of human renal and cardiovascular structure and function. Unique capabilities range from microelectrode recordings of sympathetic action potentials to proton magnetic resonance spectroscopic measurements of renal and cardiac steatosis, to measurement of glomerular filtration rate, ambulatory BP monitoring, non-invasive measurement of central aortic pressure and cardiac output – specific pathophysiological processes that could provide a common mechanistic explanation for the remarkably tight link between cardiac and renal disease as well as identifying novel therapeutic drug targets for early intervention – sufficiently early to prevent (rather than merely delay) clinical endpoints such as end-stage renal disease, stroke, myocardial infarction, and death. The Clinical and Translational Core also serves as the site for a biorepository and registry for phenotyping and genotyping patients with kidney diseases.
Organization of the Core
The core is comprised of 4 key components that provide key functions to the O’Brien Center research community including the research clinic, physiology and bench laboratory, and Biostatistics section. Each component has assigned personnel with expertise and experience in and a track record of accomplishments in their field. Together, this research team will facilitate clinical research on kidney and cardiovascular disease. The specific methods are outlined below.
The Core Directors provide oversight, direction and coordination of the component. Specifically, Dr. Toto is the overall director of the Core and oversees the Bench and Biostatistics laboratory components. Dr. Vongpatanasin oversees all aspects of the physiology laboratory. Dr. Hedayati oversees the Research Clinic.
Distinctive Features of the Core include
- Access to study populations. (e.g., The Dallas Heart and Mind, the University hospitals and the Parkland Health and Hospital Systems and Children’s Health, Texas Health Resources).
- Dedicated space for clinical research. (3500 square foot research suite is conveniently located next to our nephrology faculty combined chronic kidney disease and transplant clinic.
- Experienced and Dedicated Clinical Research Team. A team of highly trained and experienced personnel including research nurse, data entry specialist, study coordinators, and a biostatistician is available to assist investigators in design and implementation of human research.
- Physiology and Bench laboratory facilities. The Core has space, equipment and expertise for both measurements of renal and cardiovascular function as well assays for various analytes used in mechanistic renal and cardiovascular research
Clinical and Translational Core Services
- Consultation (Zhengnan.Wang@utsouthestern.edu: Zhengnan Wang)
- Initial IRB Regulatory document (e.g., Consents, HIPAAs, Flyers) preparation/eIRB submission to UTSW IRB and performance sites including response to stipulation(s) for final approval.
- Study Specific Source Document Development
- eIRB Modifications, eIRB SAE and Sponsor SAE reporting
- Annual Renewal Submission
- Study Closeout documentation and reporting
- Data collection for phenotyping human research subjects
- Training in methods of clinical and translational research including protocol development, human research subject, and institutional review board documentation
- Process Blood for plasma and serum analytes and genetic analyses
- Collect and process urine
- Exam Room usage (Zhengnan.Wang@utsouthestern.edu: Zhengnan Wang)
- Ambulatory blood pressure monitoring
- Flow mediated dilation
- Pulse wave velocity and central aortic pressure measurement
- Iothalamate Assay (Jessica.firstname.lastname@example.org: Jessica Lucas)
- Study participant recruitment and management (Zhengnan.Wang@utsouthestern.edu: Zhengnan Wang)
- Sympathetic nerve activity (Wanpen.email@example.com: Wanpen Vongpatanasin)
- Bioimpedence Spectroscopy and Non-Invasive Cardiac Output measurement (firstname.lastname@example.org: Peter Van Buren)