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
Study ID
NCT07409714
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
14 Years - 24 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
Feb 13, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Montelukast
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change in renal vascular resistance (RVR) [ Time Frame: 0 and 6 months ]

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