Evaluation of the effect of fenofibrate on the function of pancreatic beta cells in children with newly diagnosed type 1 diabetes
Medical Research Agency
Medical Research Agency
The aim of the study is to assess the effect of fenofibrate on the preservation of residual pancreatic beta cell function in children with newly diagnosed type 1 diabetes.
A randomized, double-blind, placebo-controlled, multicentre clinical trial will be conducted. The study will include 102 children aged 10-17 years with newly diagnosed type 1 diabetes, treated at the Department of Pediatrics, MUW University Clinical Centre and at the Department of Endocrinology and Diabetology, Children's Health Institute (IPCZD) in Warsaw. Diabetes mellitus type 1 will be diagnosed in accordance with the criteria of the Polish Diabetes Association. Children will be randomized to receive fenofibrate orally vs. placebo for one year. The primary endpoint will be to evaluate the function of pancreatic beta cells by comparing the area under the AUC curve in a C-peptide stimulation assay. The secondary endpoints will be: fasting c-peptide concentration and maximum c-peptide concentration in the stimulation test, autoantibodies (GADA, IA2A, ZnT8, IAA), parameters of diabetes control and glucose fluctuations (including HbA1c, mean blood glucose with standard deviation) variability index, time spent in normoglycemia), daily and basal insulin requirements, inflammatory markers.