Research Projects - Dr. Eric Felner

Research Projects (Eric I. Felner, MD)

Title: The Effect of Diet & Exercise on Biomarkers of Cardiovascular Risk and Insulin Sensitivity in Obese African American adolescents
11/04 – 11/06
Emory Medical Care Foundation Grant (EMCF) #04005

Dr. Felner was the PI of an Emory Care Foundation (EMCF) grant to study the effects of a lifestyle intervention program on insulin sensitivity and endothelial function in obese, African-American adolescents. Subjects participated in a 12-week diet and exercise program. Biochemical markers associated with cardiovascular risk and insulin sensitivity, as well as measures of endothelial function were performed before and after the diet and exercise program. The primary outcome was change in endothelial function and the secondary outcome was change in insulin sensitivity. Although the number of subjects were low, the studies indicated significant changes in those completing the program. The study is complete and the manuscript has been submitted to a peer-reviewed journal. Presently, Dr. Felner is collaborating with experts in the field of inflammatory cytokines (Dr. LouAnn Brown, PhD), Type 2 diabetes (Guillermo Umpierrez, MD), endothelial dysfunction (Dr. Bobby Khan, MD, PhD), and Laparascopic banding (Mark Wulkan, MD). Plans are underway to set up a Bariatric Center to further address obesity as well as attempt to attain funding for obesity studies. Dr. Wulkan has a grant from the pharmaceutical company who produces the laparascopic bands and dr. felner is also receiving support through that grant.

Title: Insulin Delivery through Microneedles in Type 1 Diabetes Mellitus
1/06 – 2/07
Emory Egleston Children’s Research Center Seed Grant

This study involves an alternative method of insulin delivery. Subjects with Type 1 diabetes for greater than 2-years and have worn an insulin pump for more than a year are eligible for this study. The primary endpoint is the comparison between the area-under-the-insulin–curve (AUIC) for conventional pump therapy versus AUIC for a microneedle delivery. The secondary endpoint is the comparison between anxiety between the 2 methods. Insulin delivery through a microneedle has never been reported to occur in humans. Over the past 2-years, however, Dr. Felner, who has an undergraduate degree in Chemical Engineering (B.Ch.E. 1990) from Georgia Tech, along with Mark Prausnitz, PhD, a Chemical Engineer at Georgia Tech, have successfully delivered insulin through a microscopic needle in 3 human subjects. The benefit of this alternate delivery is that it is painless and much less intimidating than the conventional insulin pump delivery method, making it ideal for children. Although the funding from this grant is complete, the team is awaiting word from a recent submission from another source. Dr. Felner will also be working on other microneedle delivery devices (i.e., immunizations) with Dr. Prausnitz. Dr. Felner was made and adjunct Associate professor of Chemical and Biomolecular Engineering at Georgia Tech this past academic year.

Title: Insulin Delivery through Microneedles in Type 1 Diabetes Mellitus
Funding: Pending but likely to start 1/2008 – 1/2013
Juvenile Diabetes Reasearch Foundation

Progress in understanding T cell-mediated immune responses have identified T cell surface molecules which may serve as safe and selective targets for therapies for immune modulation. One promising molecule is the leukocyte functional antigen-1 (LFA-1) found on T-cells. Preclinical investigations show that antibody blocking LFA-1 abrogates T-cell dependent immune processes, including rodent models of allograft rejection and T1DM. Recently a humanized monoclonal antibody to LFA-1, Efalizumab, has shown in efficacy in renal transplant clinical trials and has been FDA-approved for the T-cell-mediated autoimmune condition of severe psoriasis. In clinical use it has been safe with few minor side effects. We hypothesize that Efalizumab therapy started at initial T1DM diagnosis will protect residual beta cells from destruction and rescue patients from diabetes. To begin to test this we propose a single-center, Phase I/II randomized trial of weekly-administered Efalizumab (1 mg/kg/dose SubQ) to 13-21 year olds with newly diagnosed T1DM. Therapy is planned to continue for 20 weeks, with a possibility of limitied extension if results are promising and no significant side effects. 20 patients will receive study drug and enhanced endocrinologic and immunologic monitoring and routine care, and 10 participants will serve as controls and receive only study evaluations and routine care. Our primary endpoint will be the focus on c-peptide positivity at 12 months. Secondary endpoints will include insulin requirements, HbA1C levels, and substantial safety assessments, including evaluating the effect on pre-existing protective immunity, rates of infection, and humoral autoimmunity. We will also serially evaluate participants with advanced T-cell subset assays using multicolor flow cytometry to determine the balance of quiescent and activated, native, memory, effector, and regulatory T cells during diabetes development, and with Efalizumab. Mark Rigby, MD, PhD is the PI and Dr. Felner is a co-investigator.