[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577705":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":52,"collaborators":11,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":11,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":11,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Catholic University of the Sacred Heart","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients Undergoing Endoscopic Ultrasound","EXPERIMENTAL",null,[13],"Diagnostic Test: C-peptide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DIAGNOSTIC_TEST","C-peptide","Measurement of C-peptide at 5 time points during a standard oral glucose tolerance test (OGTT).",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Teresa Mezza","CONTACT","+393286990369","teresa.mezza@unicatt.it",[27,43],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Gemelli University Hospistal","RECRUITING","Rome","Lazio","00168","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],12.51133,41.89193,{"lat":39,"lon":38},[42],{"name":22,"role":23,"phone":11,"phoneExt":11,"email":11},{"facility":44,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":45,"geoPoint":47,"contacts":48},"Gemelli University Hospital",{"type":36,"coordinates":46},[38,39],{"lat":39,"lon":38},[49],{"name":22,"role":23,"phone":50,"phoneExt":11,"email":51},"0630156264","teresa.mezza@policlinicogemelli.it",{"type":53,"investigatorFullName":22,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Assistent Professor","100577705","study-for-the-identification-of-a-score-to-assess-intrapancreatic-fat-through-eco-elastography-and-its-correlation-with-metabolic-syndrome-and-insulin-secreting-cells-100577705",false,"NCT06801769","Study for the Identification of a Score to Assess Intrapancreatic Fat Through Eco-Elastography and Its Correlation With Metabolic Syndrome and Insulin-Secreting Cells.","Study for the Identification of a Quantitative Eco-Elastographic Score of Pancreatic Steatosis and Its Correlation With Beta-Cell Function and Metabolic Syndrome.","SPES","Inclusion Criteria:\n\n* Age between 18 and 80 years\n* HbA1c \\\u003C10% or fasting glucose \\\u003C250 mg\u002FdL\n* Ability to understand and provide informed consent regarding the procedures, data collection, and analysis.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years or \\>80 years\n* History of diabetes treated with insulin\n* HbA1c \\>10% or fasting glucose \\>250 mg\u002FdL\n* Pancreatic diseases (solid tumors\u002Fsecretory NETs\u002Fcystic fibrosis; non-secretory NETs and IPMN may be included)\n* Previous pancreatic surgery\n* Moderate anemia (Hb \\\u003C10 mg\u002FdL)\n* Severe liver failure (Child-Pugh C)\n* Non-metabolic causes of NAPLD (e.g., corticosteroid therapy, antiretrovirals, gemcitabine, octreotide, history of hemochromatosis, malnutrition, HBV\u002FHIV infections)\n* Alcohol abuse (\\>30 g\u002Fday of ethanol)\n* Pregnancy and breastfeeding\n* Inability to adequately understand informed consent and study procedures","ALL","18 Years","80 Years",{"count":67,"type":68},100,"ESTIMATED","INTERVENTIONAL",[71],"NA","\\*\\*Brief Summary of the SPES Clinical Study\\*\\*\n\nThe SPES clinical study aims to evaluate the relationship between pancreatic fat accumulation (pancreatic steatosis) and metabolic health. Pancreatic steatosis has been linked to conditions like type 2 diabetes (T2D) and metabolic syndrome, but the underlying mechanisms and its impact on beta-cell function remain poorly understood.\n\nThe primary goal of this study is to develop a quantitative ultrasound elastography score to measure the degree of pancreatic steatosis and explore how this relates to pancreatic beta-cell function and key factors associated with the development of type 2 diabetes and metabolic syndrome.\n\nA secondary goal is to categorize participants into four risk classes for type 2 diabetes based on their metabolic profiles and correlate these classes with the degree of pancreatic steatosis. This may provide insights into individual risk stratification for T2D and related complications.\n\nThe study will enroll 100 participants, aged 18 to 80, attending the Endoscopic Ultrasound Unit at the Fondazione Policlinico Universitario Agostino Gemelli in Rome. Participants will undergo endoscopic ultrasound for various clinical reasons, excluding those with pancreatic tumors, cystic fibrosis, or insulin-treated diabetes. Key inclusion criteria include controlled blood glucose levels (HbA1c \\\u003C 10% or fasting glucose \\\u003C 250 mg\u002FdL) and the ability to understand and provide informed consent.\n\nThe study is interventional but does not involve drugs or medical devices. Participants will attend a visit where medical history, physical measurements (e.g., BMI, waist circumference, blood pressure), glucose tolerance tests, and blood work will be collected. This comprehensive approach aims to better understand the metabolic implications of pancreatic steatosis and its role in type 2 diabetes development.\n\nThe study will last 24 months, including the enrollment period. Findings may contribute to improved risk stratification, prevention, and management strategies for type 2 diabetes and related conditions.",[74,75,76],"Pancreatic Steatosis","Metabolic Syndrome X","Diabetes Mellitus","2026-03-18",{"date":79,"type":80},"2026-03-20","ACTUAL",{"date":82,"type":80},"2025-03-17",{"date":84,"type":68},"2026-12",{"name":5,"class":6},2]