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SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
Sponsor: University of Colorado, Denver
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.
Key Details
Gender
All
Age Range
14 Years - 24 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-02
Completion Date
2030-02
Last Updated
2026-02-13
Healthy Volunteers
No
Conditions
Interventions
Montelukast
montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14
Montelukast Placebo
one microcrystalline cellulose tablet daily