February 2013 Archives

Medical School Assistant Professor Aaron Kelly, PhD, and Jennifer Abuzzahab, MD, Children's Hospitals and Clinics of Minnesota, received a Community Collaborative Grant from CTSI in 2010 to study the effects of the drug exenatide on extreme pediatric obesity. On Monday, February 4, the encouraging results of that study were published online in JAMA Pediatrics. 

Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist currently approved for adults with type 2 diabetes. Dr. Kelly and his team conducted a three-month, placebo-controlled trial followed by a three-month open-label extension where medication was offered to all participants. 22 individuals between 12 and 19 years of age completed the trial. Participants who received exenatide experienced a greater reduction in BMI compared with placebo (-2.7 percent), and a further reduction in BMI during the open-label period (cumulative reduction of 4 percent). The team also observed a reduction, though not statistically significant, in systolic blood pressure. 

The authors conclude that "...data from the current study provide evidence that GLP-1 receptor agonist treatment reduces BMI and elicits a potentially meaningful reduction in SPB in adolescents with severe obesity." Kelly's team collaborated with Kyle Rudser, PhD, of the CTSI Biostatistical Design and Analysis Center to complete the analysis and interpretation of the data; Rudser is also an author of the JAMA Pediatrics article. 

The CTSI Community Collaborative Grants are meant to generate pilot data for further research and funding. The authors discussed future directions for this line of research, concluding that future clinical trials should be conducted over a longer duration and should look at other health outcomes, beyond BMI and systolic blood pressure. The study was covered by Reuters and U.S. News and World Report, among others.

REDCap, or Research Electronic Data Capture, has taken off at the University of Minnesota. REDCap is a software application that provides secure, web-based data entry for clinical studies and a user-friendly interface to create online surveys and databases. 

REDCap was created at Vanderbilt University and is now being used by 549 institutions in 50 countries including the University of Minnesota Clinical and Translational Science Institute (CTSI). Within the University and CTSI, there are now almost 600 users taking advantage of REDCap's innovative features, compared to 188 just one year ago.

"I switched to REDCap from Microsoft Access and Infopath and have been wishing I had done it sooner," said Lynda Polgreen, M.D., M.S., Assistant Professor of Pediatrics. "REDCap is a user friendly database system. I can more easily review data, develop reports for a regulatory agencies, import and export data. REDCap has saved me a lot of time that used to be spent developing and trouble shooting Access and Infopath. In addition, I save time because my study coordinator was able to quickly learn to use REDCap and I anticipate she will be the primary database manager soon."

Not only does REDCap make it easier to adopt innovative practices, but it is fully supported by the CTSI's Biostatistical Design and Analysis Center and Biomedical Informatics teams. Use of REDCap is available at no cost to research teams, and additional assistance from a database developer is available at an hourly rate. Database programmer and analyst Sue Lowry provides bi-weekly introduction sessions to REDCap and is available to provide ongoing support. 

"CTSI staff were very willing and available to train my project staff who actually used the program," Kola Okuyemi, M.D., M.P.H. said. "They were readily available for trouble shooting, and Sue Lowry was great!"

Lowry and CTSI team members guide users through application upgrades. In 2012 these included a new randomization module, automated approval of changes to production projects, and new display options for survey answers. REDCap continues to evolve with an upgrade scheduled for later this year.

REDCap is used across a broad range of research studies at the University of Minnesota and around the globe.  If you are interested in learning more, register to attend a REDCap demonstration held the first Thursday and third Wednesday of every month.