[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615112":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":10,"responsibleParty":33,"collaborators":10,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":10,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":54,"overallStatus":65,"whyStopped":10,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":10},{"fullName":5,"class":6},"Shanghai 6th People's Hospital","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Normal Glucose Tolerance (NGT)",null,"Participants with normal glucose tolerance as defined by a 2-hour plasma glucose value \\\u003C 7.8 mmol\u002FL during the oral glucose tolerance test (OGTT).",{"label":13,"type":10,"description":14,"interventionNames":10},"Pre-diabetes (Pre-DM)","Participants with pre-diabetes (intermediate hyperglycemia) as defined by a 2-hour plasma glucose value between 7.8 mmol\u002FL and 11.0 mmol\u002FL during the OGTT.",{"label":16,"type":10,"description":17,"interventionNames":10},"Newly Diagnosed Type 2 Diabetes (T2DM)","Participants with newly diagnosed type 2 diabetes as defined by a 2-hour plasma glucose value ≥ 11.1 mmol\u002FL during the OGTT.",[19],{"name":20,"affiliation":21,"role":22},"Jian Zhou","Shanghai Sixth People's Hospital, Shanghai, Shanghai 200233","STUDY_CHAIR",[24,29],{"name":25,"role":26,"phone":27,"phoneExt":10,"email":28},"Jian Zhou, PhD","CONTACT","+86 021 24056515","zhoujian@sjtu.edu.cn",{"name":30,"role":26,"phone":31,"phoneExt":10,"email":32},"Yue Zhang, Master's Degree","+86 17851180860","zyzy931@sjtu.edu.cn",{"type":34,"investigatorFullName":20,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Principal Investigator, Professor, Chief Physician, Head of Department","100615112","the-cgm-ogtt-glycemic-homeostasis-study-100615112",false,"NCT07288372","The CGM-OGTT Glycemic Homeostasis Study","An Exploratory Investigation Into the Mechanism of Glycemic Homeostasis Regulation Under the Synergistic Conditions of Continuous Glucose Monitoring (CGM) and Oral Glucose Tolerance Test (OGTT)","Inclusion Criteria:\n\nTo be eligible to participate in this study, an individual must meet ALL of the following criteria:\n\n* Is aged between 18 and 70 years, inclusive.\n* And meets at least ONE of the following conditions:\n\n  * Presents with diabetes-related clinical symptoms or signs (e.g., unexplained ·polydipsia, polyphagia, polyuria, weight loss) and has been advised by a ·clinician to undergo an OGTT for diagnostic clarification.\n  * Has indicators of abnormal glucose metabolism:Impaired Fasting Glucose (IFG): Fasting venous plasma glucose ≥ 6.1 mmol\u002FL and \\\u003C 7.0 mmol\u002FL.and\u002For Glycated hemoglobin (HbA1c) in the pre-diabetes range of 5.7% to 6.4%.\n  * Has at least one of the following diabetes risk factors:Body Mass Index (BMI) ≥ 24 kg\u002Fm²；Has a first-degree relative (parent, sibling, or child) with a history of diabetes；Has a history of hypertension (or undergoing antihypertensive treatment) or dyslipidemia.\n\nExclusion Criteria:\n\n* An individual who meets ANY of the following criteria will be excluded from participation in this study:\n* Previously diagnosed with diabetes.\n* Use of medications that significantly affect glucose metabolism or gastrointestinal hormones (e.g., GLP-1 receptor agonists, DPP-4 inhibitors, glucocorticoids) within a specified washout period prior to enrollment.\n* History of gastrointestinal surgery (e.g., gastrectomy) or chronic pancreatic disease.\n* Presence of severe hepatic or renal impairment (e.g., ALT \\> 3 times the upper limit of normal, or eGFR \\\u003C 45 mL\u002Fmin\u002F1.73m²).\n* Pregnant or lactating women, or women planning to become pregnant during the study period.\n* Known allergy to soy (as the standardized meal may contain soy-based components).","ALL","18 Years","70 Years",{"count":47,"type":48},225,"ESTIMATED","OBSERVATIONAL","This is a prospective, exploratory, observational study aimed at investigating the mechanisms of glycemic homeostasis by comparing continuous glucose monitoring (CGM) data with results from the oral glucose tolerance test (OGTT).\n\nThe study plans to enroll approximately 225 participants aged 18-70 years who are at risk for or suspected of having glucose metabolism disorders, but without a prior diagnosis of diabetes. Participants will be equipped with a blinded CGM device for 10-14 days. During this period, they will perform two standardized mixed-meal tolerance tests (MMTT) at home. Subsequently, they will undergo a standard 75g OGTT at the hospital, where blood samples will be collected at multiple time points to measure glucose, insulin, C-peptide, and gastrointestinal hormones (GLP-1, GIP).\n\nBased on the 2-hour blood glucose value from the OGTT, participants will be naturally categorized into three groups for comparative analysis: Normal Glucose Tolerance (NGT), Pre-diabetes (Pre-DM), and Newly Diagnosed Type 2 Diabetes (T2DM).\n\nThe primary objective is to establish a quantitative relationship between CGM-derived parameters (e.g., glycemic variability, time-in-range) after the MMTT and the OGTT diagnostic results. Secondary objectives include assessing the feasibility and correlation between home-based MMTT and standard OGTT, exploring the impact of gastrointestinal hormone responses on daily glucose fluctuations, and investigating the association between postprandial glucose dynamics and vascular reactivity (e.g., postprandial hypotension).",[52,53],"Type 2 Diabetes","Glucose Metabolism Disorders",[55,56,57,58,59,60,61,62,63,64],"Continuous Glucose Monitoring","CGM","Oral Glucose Tolerance Test","OGTT","Mixed-Meal Tolerance Test","Glycemic Variability","Incretins","Home-Based Testing","GLP-1","GIP","NOT_YET_RECRUITING","2025-12-21",{"date":68,"type":69},"2025-12-23","ACTUAL",{"date":71,"type":48},"2025-12-18",{"date":73,"type":48},"2027-08-10",{"name":5,"class":6}]