Studying Montelukasts Effect on Kidney and Blood Vessel Health in Adults with Type 1 Diabetes and Kidney Problems

What this Trial Is About

Kidney disease often affects people with type 1 diabetes and can cause serious health issues like disability and early death. This trial is studying whether montelukast, a drug that blocks leukotrienes which are chemicals involved in inflammation, can reduce protein levels in urine, an early sign of diabetic kidney disease, and improve kidney and heart function in people with type 1 diabetes and kidney disease. The study is a randomized, placebo-controlled phase 4 trial assessing treatment effects. Participants will be randomly assigned to take either one 10mg capsule of montelukast daily or a placebo capsule daily. The treatment lasts for 6 months. Researchers will compare the effects of montelukast against placebo on kidney function and vascular health. The study uses a parallel design with quadruple masking to ensure unbiased results. During the study, participants will be monitored at the start and after 6 months to measure changes in albuminuria, brachial artery flow mediated dilation, and large elastic artery stiffness. Participants must maintain stable blood pressure and medication regimens during the study. Safety and kidney function will be closely observed throughout the trial, which runs from early 2023 to 2027.

Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes