SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Yo… (NCT07409714) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
50 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
14 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.