Clinical Trial

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

Recruiting Phase 4
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Summary
Kidney disease is a common problem among people with type 1 diabetes and can lead to disability, dialysis, and early death. Inflammation plays a key role in the development of kidney disease in type 1 diabetes and targeting leukotrienes, inflammatory chemicals the body releases in response to allergic reactions, may represent a promising therapy to slow the progression of diabetic kidney disease. The current proposal will investigate whether montelukast, a leukotriene blocker, lowers increased levels of protein in the urine (an early marker of diabetic kidney disease), and improves kidney and cardiovascular function in people with type 1 diabetes and kidney disease.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-08-09; most recent amendment 2026-06-29.
Status change: Not Yet Recruiting → Recruiting 2023-04-18
Trial Details
NCT Number NCT05498116
Lead Sponsor University of Colorado, Denver
Conditions Albuminuria
Enrollment 50 participants
Start Date 2023-01-26
Primary Completion 2027-02 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-06-30