GRADE Clinical Trial and My Experience with CUDECT!

For the last couple of years, I have been working with the CUDECT team (CU Diabetes and Endocrinology Clinical Trial Program) at the University of Colorado Anschutz Medical Campus. In this team, I am a student research assistant and do a lot of the background work for our ongoing clinical trials. We have about 10 ongoing clinical trials that investigate patients with diabetes, obesity, and/or are overweight, and Dr. Neda Rasouli is the PI for most of these studies. My role as a student lies largely in preparing study visit material including lots of paperwork, organizing kits (sample collection tubes), and supporting the clinical research coordinators in any way possible. '

While working with this team, I have learned a lot about how clinical trials begin, who funds it, and the process of collecting data and analyzation. In the past 2 years, I actually got to be a part of starting up a trial, witnessing all of the tasks including recruitment, the visits and treatment period, and helped close the trial a couple of weeks ago. Of course, as I am still a student, I mostly helped with regulatory tasks and organization of the study visits. 

One of our recently completed studies is the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). The purpose of this study was to examine the long term effects of glucose-lowering medications when added to metformin on insulin sensitivity and Beta cell function. GRADE was a randomized and open labelled study with treatment lasting up to 5 years, and had a cohort of individuals all diagnosed with type 2 diabetes (T2D) (n=4,801). This study specifically explored these 4 specific medications as used with metformin, which is already often considered a standing treatment for T2D: insulin glargine U-100, glimepirde, liraglutide, and sitagliptin. To briefly summarize the results, deterioration of Beta cell function and loss of glycemic control were seen for all 4 medications when added to metformin.

This may seem like gibberish if you have never heard of T2D medications before, but the point is, there are tons of research going into how to improve the well-being of patients with diabetes, and for myself, clinical trials (research in general) are immensely important in learning how chronic diseases can be treated. The CUDECT team in particular has given me super interesting and cool experiences to learn about how diabetes and metabolism works in the body, and I encourage you all to read this paper by our PI Dr. Rasouli et al. (2024), to dive deeper into the GRADE study! 

Resource:
Rasouli N, Younes N, Ghosh A, Albu J, Cohen RM, DeFronzo RA, Diaz E, Sayyed Kassem L, Luchsinger JA, McGill JB, Sivitz WI, Tamborlane WV, Utzschneider KM, Kahn SE; GRADE Research Group. Longitudinal Effects of Glucose-Lowering Medications on β-Cell Responses and Insulin Sensitivity in Type 2 Diabetes: The GRADE Randomized Clinical Trial. Diabetes Care. 2024 Apr 1;47(4):580-588. doi: 10.2337/dc23-1070. PMID: 38211595; PMCID: PMC10973918.

Sophia :)