NCT07409714

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

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 14 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Montelukast	montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14
DRUG	Montelukast Placebo	one microcrystalline cellulose tablet daily

Timeline

• Start date: 2026-02-01
• Primary completion: 2030-02-01
• Completion: 2030-02-01
• First posted: 2026-02-13
• Last updated: 2026-02-13

Regulatory

• FDA-regulated drug study