NCT07409714RecruitingEarly phase 1
SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 16 Jan 2026
- Start date
- 12 Oct 2026
- Primary completion date
- Dec 2030
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Type 2 diabetes
- NCT number
- NCT07409714
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 50
- From 12 Oct 2026 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of inhaled or systemic corticosteroids or long-acting beta agonists
Other illness
- Uncontrolled hypertension
- Allergy to aspirin
- Severe hepatic impairment (Child-Pugh Class C)
- History of major psychiatric disorder
- Iodine or shellfish allergy
Lab values
- eGFR \<30 ml/min/1.73m2
- Macroalbuminuria with urine albumin to creatinine ratio \>300 mg/g
Other
- 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
Who the study is looking for
- 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
Age in the registry: 14 years to 24 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.