[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560379":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":44,"studyPopulation":32,"armGroups":45,"interventions":57,"overallOfficials":32,"centralContacts":65,"locations":72,"responsibleParty":89,"collaborators":93,"id":96,"slug":32,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":32,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":32,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":32,"overallStatus":75,"whyStopped":32,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Future University in Egypt","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":32},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Fertility parameters- Luteinizing hormone","Luteinizing hormone (LH) in IU\u002FL","3-6 months",{"measure":14,"description":15,"timeFrame":12},"Fertility parameters-Follicle-stimulating hormone","Follicle-stimulating hormone (FSH) in mIU\u002FmL",{"measure":17,"description":18,"timeFrame":12},"Fertility parameters-Free androgen index","Free androgen index \\[ Time Frame: 3-6 months\\]",{"measure":20,"description":21,"timeFrame":12},"Fertility parameters-Total testosterone","Total testosterone in ng\u002FdL",{"measure":23,"description":24,"timeFrame":12},"Transvaginal ultrasonography","disappearance of PCOS",{"measure":26,"description":27,"timeFrame":12},"Menstrual diaries","Menstruation pattern",[29],{"measure":30,"description":31,"timeFrame":12},"Metabolic parameters","Fasting blood glucose (FBG) in mg\u002FdL",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":39},"QUADRUPLE",[40,41,42,43],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Incretins such as glucagon-like peptide-1(GLP-1) are gut hormones secreted after meals that enhance insulin secretion and help maintain glucose homeostasis.They also reduce hepatic glucagon release, slow gastric emptying, and suppress appetite, aiding in weight control and glycemic management.In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight\u002Fobese individuals.Conflicting results exist regarding GLP-1 levels in PCOS patients, with studies reporting reduced, normal, or increased levels.After an oral glucose tolerance test, increased GIP and lower GLP-1 concentrations have been observed in women with PCOS.\n\nReduced GLP-1 levels are also associated with impaired glucose tolerance (IGT) and impaired fasting glucose (IFG), which are early indicators of prediabetes and potential progression to Type 2 Diabetes Mellitus.Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with IFG and IGT. The study aims to compare the efficacy of Dapagliflozin to Metformin for treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).",[46,52],{"label":47,"type":48,"description":49,"interventionNames":50},"Dapagliflozin","ACTIVE_COMPARATOR","Patients will receive Dapagliflozin 10 mg once daily orally for 12 weeks (Forxiga® AstraZeneca company)",[51],"Drug: Dapagliflozin",{"label":53,"type":48,"description":54,"interventionNames":55},"Metformin","Patients will receive Metformin 1000 mg once daily orally for 12 weeks (control group) (Glucophage® Merck company)",[56],"Drug: Metformin",[58,62],{"type":59,"name":47,"description":60,"armGroupLabels":61,"otherNames":32},"DRUG","oral Dapagliflozin",[47],{"type":59,"name":53,"description":63,"armGroupLabels":64,"otherNames":32},"oral metformin",[53],[66],{"name":67,"role":68,"phone":69,"phoneExt":70,"email":71},"Nouran Omar","CONTACT","01006526452","+2","nomar@fue.edu.eg",[73],{"facility":74,"status":75,"city":76,"state":32,"zip":32,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"October 6 University Hospital","RECRUITING","Giza","Egypt","EG",{"type":80,"coordinates":81},"Point",[82,83],31.20861,30.00944,{"lat":83,"lon":82},[86],{"name":87,"role":68,"phone":88,"phoneExt":70,"email":32},"Ahmed Hussein","01001749605",{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Nouran Omar El Said","Lecturer in Pharmacy Practice & Clinical Pharmacy",[94],{"name":95,"class":6},"October 6 University","100560379",false,"NCT06576375","Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome","Efficacy of Dapagliflozin Versus Metformin in Polycystic Ovary Syndrome: A Prospective Comparative Randomized Blinded Trial.","Inclusion Criteria:\n\n* Women diagnosed with PCOS according to Rotterdam 2003 criteria National Institute of Health criteria.\n* Age: \\>18 \\\u003C40 years.\n* Infertile women (primary or secondary infertility)\n\nExclusion Criteria:\n\n* Patients with history of diabetes mellitus (Type 1 or 2).\n* Patients with liver or renal dysfunction; inflammatory diseases; autoimmune disease; cancer, acute cardiovascular event within last three months and uncontrolled endocrine or metabolic disease.\n* Use of hormonal medications, lipid-lowering (statins, etc.), anti-obesity drugs or weight loss medications (prescription or OTC) and medications known to exacerbate glucose tolerance (such as isotretinoin, hormonal contraceptives, glucocorticoids, anabolic steroids) stopped for at least 8 weeks. Use of anti-androgens that act peripherally to reduce hirsutism such as 5-alpha reductase inhibitors stopped for at least 4 weeks.\n* Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status.\n* Presence of hypersensitivity to dapagliflozin or other Sodium\u002Fglucose cotransporter 2 (SGLT2) inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions).\n* Use of Metformin, Thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors\n* Eating disorders (anorexia, bulimia) or gastrointestinal disorders.\n* Having a history of bariatric surgery.","FEMALE","18 Years","40 Years",{"count":106,"type":107},70,"ESTIMATED","INTERVENTIONAL",[110],"PHASE3","In PCOS (Polycystic Ovary Syndrome), studies have found impaired incretin secretion and activity, particularly in overweight\u002Fobese individuals.\n\nConflicting results exist regarding glucagon-like peptide-1(GLP-1) levels in PCOS patients, with studies reporting reduced, normal, or increased levels. Incretin-based therapy has been suggested as a potential treatment to reverse prediabetes risk by preserving β-cell function in patients with impaired fasting glucose(IFG and impaired glucose tolerance(IGT). The study aims to compare the efficacy of Dapagliflozin to Metformin for the treatment of non-diabetic patients with polycystic ovary syndrome (PCOS).",[113],"Polycystic Ovary Syndrome","2024-10-18",{"date":116,"type":117},"2024-10-22","ACTUAL",{"date":119,"type":117},"2024-09-02",{"date":121,"type":107},"2025-01",{"name":5,"class":6},1]