[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638518":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":22,"centralContacts":32,"locations":37,"responsibleParty":51,"collaborators":10,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":10,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University Medical Center Ho Chi Minh City (UMC)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early onset type 2 diabetes mellitus",null,"Includes patients diagnosed with type 2 diabetes mellitus according to the ADA 2024 criteria with an onset age of under 40 years",[13],"Other: Monitor and observe the clinical progression and beta cell function",{"label":15,"type":10,"description":16,"interventionNames":17},"Type 2 diabetes mellitus typically presents","Includes patients diagnosed with type 2 diabetes mellitus according to the ADA 2024 criteria, with an onset age of 40 years or older",[13],[19],{"type":6,"name":20,"description":20,"armGroupLabels":21,"otherNames":10},"Monitor and observe the clinical progression and beta cell function",[9,15],[23,27,30],{"name":24,"affiliation":25,"role":26},"Chi Khanh Hoang, Specialist physician level 1","University of Medicine and Pharmacy of Ho Chi Minh City","PRINCIPAL_INVESTIGATOR",{"name":28,"affiliation":25,"role":29},"Nam Quang Tran, Associate professor - Doctorat","STUDY_DIRECTOR",{"name":31,"affiliation":25,"role":29},"Tran Viet Thang, Doctorate",[33],{"name":24,"role":34,"phone":35,"phoneExt":10,"email":36},"CONTACT","84985578494","chi.hk@umc.edu.vn",[38],{"facility":25,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":10},"RECRUITING","Ho Chi Minh City","Cho Lon Ward","72700","Vietnam","VN",{"type":46,"coordinates":47},"Point",[48,49],106.62965,10.82302,{"lat":49,"lon":48},{"type":52,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100638518","function-of-beta-cells-in-early-onset-diabetes-mellitus-100638518",false,"NCT07574138","Function of Beta Cells in Early-onset Diabetes Mellitus","Comparison of Beta Cell Functional Changes in Patients With Early-onset Type 2 Diabetes Mellitus and Those With Typical Onset","Inclusion Criteria:\n\n* The patient is diagnosed with Type 2 Diabetes Mellitus according to the ADA 2024 criteria (Fasting Glucose ≥ 126 mg\u002Fdl, or Glucose after 2 hours of an Oral Glucose Tolerance Test ≥ 200 mg\u002Fdl, or HbA1C ≥ 6.5%, or with typical symptoms accompanied by any Glucose ≥ 200 mg\u002Fdl).\n* The duration of Type 2 Diabetes Mellitus does not exceed 10 years.\n* Classification by age of onset: Early onset group (\\\u003C 40 years) and typical onset group (≥ 40 years).\n* At least 6 months without the need for insulin and no recorded episodes of diabetic ketoacidosis since the time of diagnosis.\n* For the early-onset group: Autoantibodies (Anti-GAD, ICA) are negative and fasting C-peptide levels are \\> 0.6 nmol\u002FL.\n* The patient consents to participate in the study and signs the informed consent document.\n\nExclusion Criteria:\n\n* Pregnant women or patients with acute illnesses at the time of assessment.\n* The patient has been diagnosed with or exhibits characteristics suggestive of Type 1 Diabetes Mellitus (such as a history of ketoacidosis, C-peptide \\\u003C 0.2 nmol\u002FL).\n* Secondary diabetes mellitus due to pancreatic disorders (pancreatitis, pancreatic tumors, pancreatic resection), due to medications (glucocorticoids), or due to other endocrine disorders (Cushing's syndrome, hyperthyroidism, acromegaly).\n* Severe renal failure with an estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m².\n* Use of medications that affect beta cell function or complications such as prolonged high-dose corticosteroids, immunosuppressive agents, or chemotherapy.\n* Not of Vietnamese ethnicity.\n* Non-compliance with treatment guidelines or failure to attend scheduled follow-up appointments.","ALL",{"count":62,"type":63},296,"ESTIMATED","OBSERVATIONAL","* Research objectives: Evaluate and compare the clinical and paraclinical characteristics, complications, as well as the changes in beta cell function and HbA1C levels between two patient groups over a one-year follow-up period.\n\n  +Research design: This is a prospective cohort study, monitoring patients at 3, 6, 9, and 12 months.\n* Study Population and Sample Size: The study is planned to be conducted on 296 Vietnamese patients (accounting for a 20% dropout rate) who are being examined at the University of Medicine and Pharmacy Hospital in Ho Chi Minh City.\n* Key Evaluation Indicators: The function of beta cells and insulin resistance status are measured through the indices of HOMA-B, HOMA-IR, fasting C-peptide levels, and HbA1C levels.\n* Time and location: The study will be conducted from February 2025 to February 2028 at the Endocrinology Clinic, University Medical Center Ho Chi Minh City.",[67,68],"Type 2 Diabetes Mellitus (T2DM)","Beta Cell Function",[70,71,72],"Early-onset type 2 diabetes mellitus","Beta cell function","C-peptide","2026-05-01",{"date":75,"type":76},"2026-05-07","ACTUAL",{"date":78,"type":76},"2025-02-24",{"date":80,"type":63},"2028-02",{"name":5,"class":6},1]