Sitagliptin therapy to improve outcomes after islet autotransplantation.

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DESCRIPTION (provided by applicant): Melena Bellin, MD is an Assistant Professor in the Department of Pediatrics, Division of Pediatric Endocrinology, at the University of Minnesota (UM). In this position, she devotes 75% of her time to patient-oriented research in the field of islet transplantation. Specific goals during this career development award period will include: 1) improved knowledge in clinical trials management, immunology, and islet transplantation; 2) publication of 2 peer-reviewed manuscripts per year; 3) completion of a clinical trial as described below; and 4) submission of a R-series research grant in the last 2 years of this award. Dr. Bellin has had formal training in patient-oriented research as a student in the M.S. program in Clinical Research at UM. She has been a co-investigator in cohort studies and small non-randomized clinical trials in islet transplant. She will build upon this foundation during the career development award period through formal training in more specific areas related to her research, attendance at national and international conferences in her field, and by conducting a large randomized clinical trial. Under the guidance of Dr. Antoinette Moran, the project mentor, Dr. Bellin will conduct a randomized double-blinded controlled trial evaluating the effect of sitagliptin treatment following total pancreatectomy and islet autotransplant on insulin independence and islet function. This project will have two aims: 1) to determine if treatment with a DPP-4 inhibitor after total pancreatectomy and islet autotransplant increases the proportion of recipients achieving insulin independence, and 2) to evaluate whether preoperative tests of islet function correlate with islet yield. Although incretin-based therapies have been used in very small, non-randomized trials of islet allotransplantation, this will be the first large randomized study to investigate such a therapy in islet autotransplant. Research projects will be conducted under the guidance of a mentor and co-mentors experienced in the fields of diabetes and islet transplant research-- Dr. Antoinette Moran, Dr. Bernhard Hering, and Dr. David Sutherland. The extensive experience with islet transplants at UM makes this an ideal environment for this research focus. Overall scholarly progress will be monitored by regular meetings with an advisory committee.