NCT07409714 SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
| NCT ID | NCT07409714 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Colorado, Denver |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-10-12 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-10-12 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07409714 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 24 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07409714 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07409714 currently recruiting?
Yes, NCT07409714 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Colorado, Denver to inquire about joining.
Where is the NCT07409714 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT07409714 clinical trial?
NCT07409714 is sponsored by University of Colorado, Denver. The trial plans to enroll 50 participants.
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