Recruiting
Early Phase 1

Montelukast

Sponsor:

University of Colorado, Denver

Code:

NCT07409714

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 14 - 24

Healthy Volunteers: Not accepted

Interventions

Montelukast

Montelukast Placebo

Study Details

Brief 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

Study ID

NCT07409714

Start date

Oct 12, 2026

Status verified date

Oct, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 14-24 years
  • Tanner stage >2
  • Diabetes onset <18 years of age and <10 years duration prior to study start
  • HgbA1c <10%
  • Blood pressure <130/80 mm Hg prior to randomization
  • Stable anti-hypertensive regimen for at least one month prior to randomization
  • BMI < 40 kg/m2
  • If on SGLT2 inhibitor, ACEi/ARB or GLP-1RA, stable dose for 4 weeks
  • Patient or guardian able to provide consent

Exclusion Criteria:

  • T1D
  • Episode of diabetic ketoacidosis or hyperosmolar hyperglycemia within 60 days
  • Uncontrolled hypertension
  • eGFR <30 ml/min/1.73m2
  • Macroalbuminuria with urine albumin to creatinine ratio >300 mg/g
  • Current participation in another research study
  • Pregnancy or planning to become pregnant or currently breastfeeding
  • Allergy to aspirin
  • Severe hepatic impairment (Child-Pugh Class C)
  • History of major psychiatric disorder
  • Use of inhaled or systemic corticosteroids or long-acting beta agonists
  • Iodine or shellfish allergy

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Montelukast

placebo comparator: Placebo

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

Primary outcome measure

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

Central Contacts and Locations

Locations

University of Colorado

Recruiting

Aurora, Colorado, United States, 80010

Contacts

Angelina Dixon

720-441-3194angelina.dixon@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

  • montelukast
  • diabetes
  • type two diabetes
  • kidney function
  • blood vessel function
  • inflammation
  • smart2d

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.