SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Montelukast, Montelukast Placebo.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 14 years — 24 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Montelukast
montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14 - Drug Montelukast Placebo
one microcrystalline cellulose tablet daily
Primary outcome measures
- Change in renal vascular resistance (RVR) [Time frame: 0 and 6 months]
Secondary outcome measures (6)
- Change in Brachial artery flow mediated dilation (FMD) [Time frame: 0 and 6 months]
- Change in aortic pulse-wave velocity (PWV) [Time frame: 0 and 6 months]
- Change in endovascular biopsy [Time frame: 0 and 6 months]
- Change in urinary sCD163 [Time frame: 0 and 6 months]
- Change in urinary MCP-1 [Time frame: 0 and 6 months]
- Change in plasma MCP-1 [Time frame: 0 and 6 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07409714 · 25-2690