[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07685886":3,"trial-entities:NCT07685886":112,"trial-summary:NCT07685886":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":40,"secondary_outcomes":45,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":84,"locations":87,"central_contacts":104,"overall_officials":107,"references":110,"see_also_links":111},"NCT07685886","26-1415","MIRACLE-T2D Montelukast Intervention for Renal, Cardiovascular and Eye Health in Type 2 Diabetes","NOT_YET_RECRUITING","2031-08-31","2026-06","2026-07-06","2026-09-01","University of Colorado, Denver","OTHER",true,"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.",null,[18,19,20,21],"Diabetes","Kidney Disease","Vascular Disease","Retinopathy",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE4",{"count":28,"type":29},110,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Montelukast","10 my by mouth daily",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"Placebo","One capsule by mouth daily",[37],[41],{"measure":42,"description":43,"timeFrame":44},"Change from baseline in urine albumin excretion at 12 months","24-hour urine albumin","From enrollment to the end of treatment at 12 months",[46,49,52,56],{"measure":47,"timeFrame":48},"Change from baseline in creatinine clearance at 12 months","From time of enrollment until end of treatment at 12 months",{"measure":50,"description":51,"timeFrame":44},"Change from baseline in vascular endothelial function at 12 months","Measured by brachial artery flow mediated dilation",{"measure":53,"description":54,"timeFrame":55},"Change from baseline in arterial stiffness at 12 months","Measured by aortic pulse wave velocity","From enrollment until end of treatment at 12 months",{"measure":57,"description":58,"timeFrame":59},"Change from baseline in diabetic retinopathy at 12 months","Measured by OCTA","From enrollment until to the end of treatment at 12 months","ALL","18 Years","80 Years",false,{"inclusion":65,"exclusion":74,"raw_text":83},[66,67,68,69,70,71,72,73],"Diabetes type 2","Urine albumin to creatinine ratio 30-5000 mg\u002Fg","CKD stage 2-3 (eGFR 30-89 ml\u002Fmin\u002F1.73m2)","Blood pressure \\\u003C 140\u002F90 mmHg prior to randomization","BMI \\\u003C or = to 40 kg\u002Fm2","Use of ACEi or ARB with stable dose for 4 weeks","if on SGLT2i or GLP-1RA, stable dose for 3 months prior to baseline","Able to provide consent",[75,76,77,78,79,80,81,82],"Type 1 diabetes","Uncontrolled hypertension","Hemoglobin A1C \\>10%","Pregnancy or planning to become pregnant or currently breastfeeding","Allergy to aspirin","History of major psychiatric disorder","Use of inhaled or systemic corticosteroids or long-acting beta agonists","Proliferative retinopathy requiring current treatment","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",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":89,"city":90,"state":91,"zip":92,"country":93,"contacts":94,"geoPoint":101},"University of Colorado Denver","Aurora","Colorado","80045","United States",[95,100],{"name":96,"role":97,"phone":98,"email":99},"Jessica Kendrick","CONTACT","303-724-4837","jessica.kendrick@cuanschutz.edu",{"role":97,"email":99},{"lat":102,"lon":103},39.72943,-104.83192,[105],{"name":106,"role":97,"phone":98,"email":99},"Jessica Kendrick, MD MPH",[108],{"name":106,"affiliation":12,"role":109},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":116},[114,115],"Chronic Kidney Disease","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":14,"summary":118,"prompt_version":128},{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is an interventional study planning to enroll 110 participants. It will compare montelukast to a placebo.","completed","Montelukast for Kidney, Eye, and Vascular Health in Type 2 Diabetes","This study is looking into whether montelukast, a medication currently used for asthma and allergies, can help improve kidney, eye, and blood vessel health in adults with type 2 diabetes and kidney disease. Diabetes can cause damage to these areas, and montelukast works by targeting certain inflammatory substances in the body. You might be able to join if you are between 18 and 80 years old, have type 2 diabetes, and have certain levels of kidney function (eGFR between 30-89 ml\u002Fmin\u002F1.73m2) and protein in your urine (urine albumin to creatinine ratio 30-5000 mg\u002Fg). The study will compare montelukast (10 mg by mouth daily) to a placebo (an inactive capsule). Researchers will measure changes in protein in your urine after 12 months to see if montelukast is effective. The current recruitment status is unclear.","Participants will be followed for 12 months, which is the duration of the treatment period.",133,"You would take either montelukast or a placebo by mouth daily for 12 months. Your urine albumin excretion will be measured at the start and end of this 12-month period.","Not stated in the trial record.",[33,37],"v2"]