Einstein Translational Research Core

Overview

The primary mission of the Einstein-Sinai Diabetes Research Center Translational Research Core (TRC) is to promote high-quality diabetes translational research, through delivery of services including consultation, technical support, and training and mentoring in clinical research methods that are specifically applicable to diabetes, its complications and related metabolic defects. Core services encompass first-in-human and mechanistic studies in integrative physiology, clinical trials involving diabetes and obesity, and patient-centered outcomes research, thus spanning the full spectrum of translational research.

Objectives

1. Services to promote “T1” translational research initiatives
   The primary goal to support T1 translational efforts is to facilitate generation of proof-of-concept and/or preliminary data to promote timely submission of successful applications for extramural funding. The Core provides consultation and assistance with study design and implementation for laboratory-based investigators regarding appropriate metabolic studies to address innovative research questions in human subjects.
2. Services to support “T2” and “T3” translational research initiatives
   These Core activities are designed to support new clinical investigators (or those new to diabetes) in the development of proposals and collection of preliminary data that will support competitive grant applications. TRC provides consultation and assistance to investigators in diabetes-specific aspects of study design and methodology, including cohort studies and small scale clinical trials.
3. Services to support “T4” research initiatives
   These Core services are designed to facilitate community engagement, particularly in studying determinants of diabetes-related health outcomes and public health initiatives to reduce health disparities. The TRC provides expertise for the development, enhancement and implementation of community-based research related to diabetes prevention and control.
4. Training and mentoring in clinical research methodology
   The Core provides both informal mentoring and a structured seminar series devoted to diabetes specific clinical research methodology.

Services

1. Consultation and study design assistance regarding appropriate metabolic studies to address specific research questions
2. Consultation on the implementation and interpretation of research procedures:Consultation on the implementation and interpretation of research procedures:
   • measurement of body composition (by dual-energy X-ray absorptiometry or bio-impedance analysis) and anthropometrics
   • measurement of energy expenditure
   • glucose tolerance tests (e.g., oral glucose tolerance tests (OGTT), frequently sampled intravenous glucose tolerance tests (FSIVGTT) and standard mixed meal challenge tests
3. Consultation and technical support for the performance and interpretation of in vivo physiologic procedures:
   • stepped hyperinsulinemic-euglycemic clamp studies to assess hepatic and peripheral insulin sensitivity and glucose effectiveness, including use of tracer techniques (e.g., 6, 6-deuterated glucose)
   • pancreatic clamp studies (involving somatostatin infusion with basal insulin, growth hormone and glucagon replacement)
   • hypoglycemic clamp techniques for the study of hypoglycemia counterregulation
   • indirect calorimetry for assessment of energy balance
   • biopsies of muscle and adipose tissue for subsequent subcellular fractionation and analyses
   • closed-loop “artificial pancreas” for maintenance of euglycemia and assessment of insulin secretion
   • assessment of insulin secretion using stepped hyperglycemic clamps and in vivo measurement of rates of insulin biosynthesis and insulin secretion in humans using a novel stable isotope dilution method
   • use of reactive hyperemia peripheral arterial tonometry and skin intrinsic fluorescence in human metabolic studies
4. Assistance with recruitment of subjects with (or at risk of) diabetes (type 1 and type 2); services include consultation on recruitment strategies and direct outreach efforts for selected research protocols
5. Consultation for regulatory compliance (e.g., IRB, FDA for investigational use INDs, etc.).
6. Consultation on “T4” research methodologies: CBPR, Dissemination and Implementation Science
7. Consultation with public health agencies and other regional or national research groups in diabetes specific issues related to implementation and dissemination of evidence-based interventions and policy development
8. Diabetes clinical research seminar series: This seminar series is open to trainees (fellows, post-docs, residents) and faculty members and is conducted jointly by faculty at Einstein, Mt. Sinai and affiliates.