[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646974":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":56,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":25,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Montelukast","EXPERIMENTAL","10 mg capsule by mouth daily",[13],"Drug: Montelukast",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","One matching capsule by mouth daily",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","10 my by mouth daily",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"One capsule by mouth daily",[15],[30],{"name":31,"affiliation":5,"role":32},"Jessica Kendrick, MD MPH","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","303-724-4837","jessica.kendrick@cuanschutz.edu",[39],{"facility":40,"status":25,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of Colorado Denver","Aurora","Colorado","80045","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-104.83192,39.72943,{"lat":50,"lon":49},[53,55],{"name":54,"role":35,"phone":36,"phoneExt":25,"email":37},"Jessica Kendrick",{"name":25,"role":35,"phone":25,"phoneExt":25,"email":37},{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100646974","phase-4-miracle-t2d-montelukast-intervention-for-renal-cardiovascular-and-eye-health-in-type-2-diabetes-100646974",false,"NCT07685886","MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes","MIRACLE-T2D","Inclusion Criteria:\n\n* Diabetes type 2\n* Urine albumin to creatinine ratio 30-5000 mg\u002Fg\n* CKD stage 2-3 (eGFR 30-89 ml\u002Fmin\u002F1.73m2)\n* Blood pressure \\\u003C 140\u002F90 mmHg prior to randomization\n* BMI \\\u003C or = to 40 kg\u002Fm2\n* Use of ACEi or ARB with stable dose for 4 weeks\n* if on SGLT2i or GLP-1RA, stable dose for 3 months prior to baseline\n* Able to provide consent\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Uncontrolled hypertension\n* Hemoglobin A1C \\>10%\n* Pregnancy or planning to become pregnant or currently breastfeeding\n* Allergy to aspirin\n* History of major psychiatric disorder\n* Use of inhaled or systemic corticosteroids or long-acting beta agonists\n* Proliferative retinopathy requiring current treatment","ALL","18 Years","80 Years",{"count":69,"type":70},110,"ESTIMATED","INTERVENTIONAL",[73],"PHASE4","Diabetes mellitus type 2 is associated with significant morbidity and mortality; and identifying new treatments for diabetes complications to be used alone or in combination with other therapies is a high priority. Hyperglycemia triggers proinflammatory pathways leading to damage in the kidneys, eyes and blood vessels; thus targeting proinflammatory lipid mediators called leukotrienes may represent a promising therapy for diabetes complications. This clinical trial seeks to investigate whether montelukast, a leukotriene antagonist, improves kidney, eye and vascular function in adult participants with type 2 diabetes and kidney disease.",[76,77,78,79],"Diabetes","Kidney Disease","Vascular Disease","Retinopathy","NOT_YET_RECRUITING","2026-06-29",{"date":83,"type":84},"2026-07-06","ACTUAL",{"date":86,"type":70},"2026-09-01",{"date":88,"type":70},"2031-08-31",{"name":5,"class":6},1]