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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 14 Years and 24 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Montelukast
  • Drug: Montelukast
    montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14
Placebo Comparator
Placebo
  • Drug: Montelukast Placebo
    one microcrystalline cellulose tablet daily

Recruiting Locations

University of Colorado
Aurora, Colorado 80010
Contact:
Angelina Dixon
7204413194
angelina.dixon@cuanschutz.edu

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.