drugset / Trial / NCT07409714

SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes

NCT07409714

Phase 0 Not yet recruiting 50 enrolled University of Colorado, Denver
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Adolescents and young adults (AYA) with type 2 diabetes (T2D) have a more severe phenotype than what is seen in youth-onset type 1 diabetes or adult-onset T2D including earlier kidney and cardiovascular disease complications; and prioritizing new treatments, either for standalone use or in combination with other therapies is critical. T2D triggers the release of proinflammatory mediators called cysteinyl leukotrienes leading to damage to the kidneys and blood vessels. This clinical trial will evaluate the effects of montelukast, a cysteinyl leukotriene inhibitor, on kidney and vascular function in AYA with T2D to help direct future diabetes care to limit diabetic kidney and cardiovascular disease complications.

Timeline

Start
2026-07
Primary completion
2030-02
Completion
2030-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Montelukast Other / unclassified 5 mg
Subject Montelukast Other / unclassified 10 mg