[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100368269":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":26,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":26,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":26,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":67,"locationsCount":68},{"fullName":5,"class":6},"Sadat City University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","PLACEBO_COMPARATOR","50 patients will receive metformin up to 2000mg\u002Fdaily (Control group)",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Montelukast group","EXPERIMENTAL","50 patients will receive a combination of metformin up to 2000 mg\u002Fdaily and montelukast (10 mg \u002Fday).",[19],"Drug: Montelukast 10mg",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Montelukast 10mg","Montelukast is an orally dosed drug (available as a chewable tablet) which is FDA-approved for the treatment of chronic asthma and prophylaxis and the prevention of exercise-induced bronchoconstriction. It is also approved for the relief of symptoms of both seasonal and perennial allergic rhinitis.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Placebo tablet once daily",[9],[32],{"facility":33,"status":26,"city":34,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Faculty of Medicine","Shebin Elkom","Egypt","EG",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mahmoud Samy Abdallah","Lecturer of Clinical Pharmacy, PhD.","100368269","early-phase-1-investigation-the-safety-and-efficacy-of-the-antileukotriene-agents-montelukast-as-adjuvant-therapy-in-obese-patients-with-type-2-diabetes-mellitus-100368269",false,"NCT04075110","Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus","Investigation the Safety and Efficacy of The Antileukotriene Agents, Montelukast, as Adjuvant Therapy in Obese Patients With Type 2 Diabetes Mellitus: A Randomized, Controlled Trial","Inclusion Criteria:\n\n\\- type 2 diabetic patients who had body mass index (BMI) ≥ 30 kg\u002Fm2 , were treated with metformin alone and had ages ranging from 18 to 60 years.\n\nExclusion Criteria:\n\n* patients who had any other inflammatory disease\n* patients with cardiovascular,\n* patients with asthma\n* patients with severe hepatic\n* patients with renal disease,\n* patients with epilepsy\n* pregnant or lactating females.","ALL","18 Years","60 Years",{"count":52,"type":53},100,"ACTUAL","INTERVENTIONAL",[56],"EARLY_PHASE1","The aim of the current study is to evaluate the safety and efficacy of Montelukast in treatment of obese patients with type 2 diabetes (T2DM).",[59],"Obesity; Endocrine; Diabetes Type 2","COMPLETED","2023-04-10",{"date":63,"type":53},"2023-04-11",{"date":65,"type":53},"2019-07-01",{"date":61,"type":53},{"name":5,"class":6},1]