Montelukast for Kidney and Blood Vessel Health in Young People With Type 2 Diabetes
Tests montelukast on kidney and blood vessel health in young people with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
Key facts
- Where
- Aurora, United StatesSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 14 and 24 years old?
Source: NCT07409714, who can take part
Where in United States
- University of ColoradoAurora, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Colorado, Denver
- Trial code
- NCT07409714
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
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.
Inclusion: 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: Use of inhaled or systemic corticosteroids or long-acting beta agonists; Uncontrolled hypertension; Allergy to aspirin; Severe hepatic impairment (Child-Pugh Class C); History of major psychiatric disorder; Iodine or shellfish allergy; eGFR <30 ml/min/1.73m2; Macroalbuminuria with urine albumin to creatinine ratio >300 mg/g; T1D; Episode of diabetic ketoacidosis or hyperosmolar hyperglycemia within 60 days; Current participation in another research study; Pregnancy or planning to become pregnant or currently breastfeeding.