[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477526":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","One capsule daily",[13],"Other: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Montelukast","EXPERIMENTAL","One 10mg capsule daily",[19],"Drug: Montelukast",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","10mg daily",[15],null,{"type":6,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"1 capsule daily",[9],[30],{"name":31,"affiliation":32,"role":33},"Jessica Kendrick, MD","University of Colorado Denver | Anschutz","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Jessica Kendrick","CONTACT","3037244837","Jessica.Kendrick@cuanschutz.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of Colorado Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-104.83192,39.72943,{"lat":53,"lon":52},[56],{"name":31,"role":37,"phone":57,"phoneExt":25,"email":58},"303-724-4837","jessica.kendrick@cuanschutz.edu",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100477526","phase-4-effect-of-montelukast-on-kidney-and-vascular-function-in-type-1-diabetes-100477526",false,"NCT05498116","Effect of Montelukast on Kidney and Vascular Function in Type 1 Diabetes","Inclusion Criteria:\n\n* Age 18-80 years\n* Type 1 diabetes for at least 5 years\n* Urine albumin to creatinine ratio 30-5000 mg\u002Fg on first morning void\n* eGFR 30-89 ml\u002Fmin\u002F1.73m2 at time of screening\n* Blood pressure \\\u003C140\u002F90 mm Hg prior to randomization\n* Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker with stable dose for 4 weeks\n* BMI \\\u003C 40 kg\u002Fm2 (FMDBA measurements can be inaccurate in severely obese patients).\n* Stable anti-hypertensive regimen for at least one month prior to randomization\n* Stable regimen of insulin delivery, i.e. automated insulin delivery (AID) system or multiple daily injections) 4 weeks prior to randomization\n* Sedentary or recreationally active (≤2 days of vigorous aerobic exercise as vigorous exercise may affect vascular function measurements)\n* Able to provide consent\n\nExclusion Criteria:\n\n* Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year\n* Uncontrolled hypertension\n* Factors judged to limit adherence to interventions\n* Anticipated initiation of dialysis or kidney transplantation within 6 months\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 (higher risk of neuropsychiatric reaction)\n* Penicillin allergy\n* Iodine allergy\n* Shellfish allergy\n* Current use of phenobarbital, rifampin or carbamazepine","ALL","18 Years","80 Years",{"count":71,"type":72},50,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","Kidney disease is a common problem among people with type 1 diabetes and can lead to disability, dialysis, and early death. Inflammation plays a key role in the development of kidney disease in type 1 diabetes and targeting leukotrienes, inflammatory chemicals the body releases in response to allergic reactions, may represent a promising therapy to slow the progression of diabetic kidney disease. The current proposal will investigate whether montelukast, a leukotriene blocker, lowers increased levels of protein in the urine (an early marker of diabetic kidney disease), and improves kidney and cardiovascular function in people with type 1 diabetes and kidney disease.",[78],"Albuminuria","2026-06-29",{"date":81,"type":82},"2026-06-30","ACTUAL",{"date":84,"type":82},"2023-01-26",{"date":86,"type":72},"2027-04",{"name":5,"class":6},1]