[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652818":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":89,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"The 95th Hospital of Putian，Putian, Fujian, China","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin groups","ACTIVE_COMPARATOR","Continue monotherapy with metformin (maintain the original dose).",[13],"Drug: Metformin",{"label":15,"type":16,"description":17,"interventionNames":18},"Metformin+ Dapagliflozin group","EXPERIMENTAL","Metformin (maintain the original dose) + Dapagliflozin 10 mg\u002Fday",[19],"Drug: Metformin + Dapagliflozin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metformin + Dapagliflozin","Maintain the stable pre-enrollment dose of metformin (≥1500 mg\u002Fday or maximum tolerated dose) plus dapagliflozin 10 mg\u002Fday orally, administered once daily before breakfast, for 3 consecutive months.\n\nOther concomitant medications (e.g., antihypertensives, lipid-lowering agents) for both groups should remain unchanged during the study period unless clinically necessary adjustments are required.\n\nPatients should be instructed to maintain stable dietary and exercise habits throughout the study.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Metformin","Maintain the stable pre-enrollment dose of metformin monotherapy (≥1500 mg\u002Fday or maximum tolerated dose) for 3 consecutive months.\n\nOther concomitant medications (e.g., antihypertensives, lipid-lowering agents) for both groups should remain unchanged during the study period unless clinically necessary adjustments are required.\n\nPatients should be instructed to maintain stable dietary and exercise habits throughout the study.",[9],[32],{"name":33,"affiliation":34,"role":35},"Rongfeng Zhu","The 95th Hospital of Putian","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Rongfeng Zhu, Dr","CONTACT","+8613706058931","123357213@qq.com",[43],{"facility":44,"status":26,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"The Ethics Committee of Putian 95 Hospital","Putian","Fujian","351100","China","CN",{"type":51,"coordinates":52},"Point",[53,54],119.01028,25.43944,{"lat":54,"lon":53},[57,61],{"name":58,"role":39,"phone":59,"phoneExt":26,"email":60},"Xuebai Chen","18760590880","Chenxuebai@126.com",{"name":26,"role":39,"phone":26,"phoneExt":26,"email":41},{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100652818","metformin-dapagliflozin-effects-on-igf-1-in-male-t2dm-with-masld-100652818",false,"NCT07778719","Metformin-Dapagliflozin Effects on IGF-1 in Male T2DM With MASLD","Effects of Metformin Combined With Dapagliflozin on Serum IGF-1 Levels in Male Patients With Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Steatotic Liver Disease","MDEITM","Inclusion Criteria:\n\n1. Males aged 30-60 years;\n2. Meeting the WHO diagnostic criteria for type 2 diabetes mellitus, with HbA1c levels between 7.0% and 10.0%;\n3. Having received a stable dose of metformin (≥1500 mg\u002Fday or the maximum tolerated dose) as monotherapy for at least 8 weeks;\n4. Meeting the diagnostic criteria for MASLD: Controlled Attenuation Parameter (CAP) value ≥248 dB\u002Fm detected, with the presence of at least one cardiometabolic risk factor;\n5. No prior use of SGLT2 inhibitors, insulin secretagogues, insulin, or GLP-1 receptor agonists;\n6. Willing to participate voluntarily and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes mellitus or other specific types of diabetes;\n2. Weekly alcohol intake exceeding 210g for males;\n3. Concomitant chronic liver diseases (viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, etc.);\n4. Known pituitary or hypothalamic diseases affecting the GH-IGF-1 axis;\n5. Previous or current use of GH preparations or IGF-1 preparations;\n6. Baseline estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m²;\n7. Previous diagnosis of cardiovascular diseases (coronary heart disease, stroke, heart failure) or severe liver diseases (decompensated cirrhosis);\n8. Active malignant tumors;\n9. Allergy to dapagliflozin or similar drugs;\n10. Use of medications affecting IGF-1 levels (such as oral estrogens, high-dose glucocorticoids) within the past 3 months;\n11. Diabetic ketoacidosis, severe infection, or surgical stress within 1 month prior to enrollment.","MALE","30 Years","60 Years",{"count":76,"type":77},84,"ESTIMATED","INTERVENTIONAL",[80],"NA","This is a 3-month, single-center, prospective, randomized, parallel-controlled, open-label trial investigating the effects of metformin combined with dapagliflozin on serum IGF-1 levels in male patients with type 2 diabetes mellitus (T2DM) and metabolic dysfunction-associated steatotic liver disease (MASLD). A total of 84 eligible male patients (aged 30-60 years, HbA1c 7.0%-10.0%, CAP ≥248 dB\u002Fm, on stable metformin monotherapy for ≥8 weeks) will be randomized 1:1 to either continue metformin alone or receive metformin plus dapagliflozin 10 mg\u002Fday for 12 weeks. The primary endpoint is the change in serum IGF-1 from baseline to 3 months between groups. Secondary endpoints include changes in hepatic steatosis (CAP), liver stiffness (LSM), FIB-4 index, metabolic parameters, and safety outcomes. The study aims to determine whether adding dapagliflozin to metformin can restore the suppressed GH-IGF-1 axis and provide mechanistic insights into its hepatoprotective effects.",[83,84],"Type 2 Diabetes","Metabolic Dysfunction-Associated Steatotic Liver Disease",[86,28,87,88,84],"Dapagliflozin","Serum IGF-1","Type 2 Diabetes Mellitus","NOT_YET_RECRUITING","2026-08-19",{"date":92,"type":93},"2026-08-21","ACTUAL",{"date":95,"type":77},"2026-10-01",{"date":97,"type":77},"2027-12-11",{"name":5,"class":6},1]