[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624444":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":25,"studyPopulation":25,"armGroups":41,"interventions":52,"overallOfficials":25,"centralContacts":25,"locations":61,"responsibleParty":82,"collaborators":25,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":25,"eligibilityCriteria":89,"healthyVolunteers":86,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":25,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Change in renal vascular resistance (RVR)","Change in RVR from baseline to 6 months. RVR is calculated as mean arterial pressure (MAP)\u002Frenal blood flow (RBF). MAP is measured using a blood pressure cuff and RBF is calculated using p-aminohippurate clearance (PAH clearance).","0 and 6 months",[14,17,20,23,26,28],{"measure":15,"description":16,"timeFrame":12},"Change in Brachial artery flow mediated dilation (FMD)","Change in FMD from baseline to 6 months, measured using high-resolution ultrasonography",{"measure":18,"description":19,"timeFrame":12},"Change in aortic pulse-wave velocity (PWV)","Change in PWV from baseline to 6 months, measured using a transcutaneous tonometer",{"measure":21,"description":22,"timeFrame":12},"Change in endovascular biopsy","Change in endovascular biopsy from baseline to 6 months. Venous endothelial cells will be collected from the intima of the vessel using 2 sterile J-wires advanced and retracted through an 18-gauge catheter, then will be incubated with monoclonal antibodies for Nf-KB.",{"measure":24,"description":25,"timeFrame":12},"Change in urinary sCD163",null,{"measure":27,"description":25,"timeFrame":12},"Change in urinary MCP-1",{"measure":29,"description":25,"timeFrame":12},"Change in plasma MCP-1",{"allocation":31,"interventionModel":32,"interventionModelDescription":25,"primaryPurpose":33,"observationalModel":25,"timePerspective":25,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":25,"whoMasked":36},"QUADRUPLE",[37,38,39,40],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[42,47],{"label":43,"type":44,"description":25,"interventionNames":45},"Montelukast","EXPERIMENTAL",[46],"Drug: Montelukast",{"label":48,"type":49,"description":25,"interventionNames":50},"Placebo","PLACEBO_COMPARATOR",[51],"Drug: Montelukast Placebo",[53,57],{"type":54,"name":43,"description":55,"armGroupLabels":56,"otherNames":25},"DRUG","montelukast 10 mg daily for patients aged 15 and older, 5 mg daily for patients aged 14",[43],{"type":54,"name":58,"description":59,"armGroupLabels":60,"otherNames":25},"Montelukast Placebo","one microcrystalline cellulose tablet daily",[48],[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"University of Colorado","RECRUITING","Aurora","Colorado","80010","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-104.83192,39.72943,{"lat":74,"lon":73},[77],{"name":78,"role":79,"phone":80,"phoneExt":25,"email":81},"Angelina Dixon","CONTACT","720-441-3194","angelina.dixon@cuanschutz.edu",{"type":83,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100624444","early-phase-1-smart-2d-study-of-montelukasts-effects-on-renal-and-cardiovascular-health-in-adolescents-and-young-adults-with-type-2-diabetes-100624444",false,"NCT07409714","SMART 2D: Study of Montelukast's Effects on Renal and Cardiovascular Health in Adolescents and Young Adults With Type 2 Diabetes","Inclusion Criteria:\n\n* Age 14-24 years\n* Tanner stage \\>2\n* Diabetes onset \\\u003C18 years of age and \\\u003C10 years duration prior to study start\n* HgbA1c \\\u003C10%\n* Blood pressure \\\u003C130\u002F80 mm Hg prior to randomization\n* Stable anti-hypertensive regimen for at least one month prior to randomization\n* BMI \\\u003C 40 kg\u002Fm2\n* If on SGLT2 inhibitor, ACEi\u002FARB or GLP-1RA, stable dose for 4 weeks\n* Patient or guardian able to provide consent\n\nExclusion Criteria:\n\n* T1D\n* Episode of diabetic ketoacidosis or hyperosmolar hyperglycemia within 60 days\n* Uncontrolled hypertension\n* eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2\n* Macroalbuminuria with urine albumin to creatinine ratio \\>300 mg\u002Fg\n* Current participation in another research study\n* Pregnancy or planning to become pregnant or currently breastfeeding\n* Allergy to aspirin\n* Severe hepatic impairment (Child-Pugh Class C)\n* History of major psychiatric disorder\n* Use of inhaled or systemic corticosteroids or long-acting beta agonists\n* Iodine or shellfish allergy","ALL","14 Years","24 Years",{"count":94,"type":95},50,"ESTIMATED","INTERVENTIONAL",[98],"EARLY_PHASE1","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.",[101],"Type 2 Diabetes",[103,104,105,106,107,108,109],"montelukast","diabetes","type two diabetes","kidney function","blood vessel function","inflammation","smart2d","2026-10-02",{"date":112,"type":113},"2026-10-06","ACTUAL",{"date":115,"type":95},"2026-10-12",{"date":117,"type":95},"2031-12",{"name":5,"class":6},1]