[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644615":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":24,"centralContacts":28,"locations":10,"responsibleParty":34,"collaborators":10,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":56,"overallStatus":71,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":10},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,12,15,18,21],{"label":9,"type":10,"description":11,"interventionNames":10},"Pancreatic Surgery for Non-Endocrine Pancreatic Disease",null,"Adults undergoing partial or total pancreatectomy for non-endocrine pancreatic disease. Participants will undergo clinical evaluation, metabolic phenotyping, imaging assessments, biomarker measurements, gut microbiome profiling from stool samples, and Genetic Risk Score determination. Pancreatic and adipose tissue specimens obtained during clinically indicated surgery may be analyzed for histopathological, molecular, and multi-omic studies.",{"label":13,"type":10,"description":14,"interventionNames":10},"Pancreatic Ductal Adenocarcinoma Undergoing Pancreatectomy","Adults with pancreatic ductal adenocarcinoma undergoing partial or total pancreatectomy. Participants will undergo clinical evaluation, metabolic phenotyping, imaging assessments, biomarker measurements, gut microbiome profiling from stool samples, and Genetic Risk Score determination. Pancreatic and adipose tissue specimens obtained during clinically indicated surgery may be analyzed for histopathological, molecular, and multi-omic studies.",{"label":16,"type":10,"description":17,"interventionNames":10},"Chronic or Previous Pancreatitis","Adults with chronic pancreatitis or a previous episode of acute pancreatitis. Participants will undergo clinical evaluation, metabolic phenotyping, imaging assessments, biomarker measurements, gut microbiome profiling from stool samples, and Genetic Risk Score determination.",{"label":19,"type":10,"description":20,"interventionNames":10},"Individuals at Risk for Type 2 Diabetes","Adults at increased risk of type 2 diabetes, including individuals with impaired fasting glucose and\u002For impaired glucose tolerance, without exocrine pancreatic disease. Participants will undergo clinical evaluation, metabolic phenotyping, imaging assessments, biomarker measurements, gut microbiome profiling from stool samples, and Genetic Risk Score determination.",{"label":22,"type":10,"description":23,"interventionNames":10},"Newly Diagnosed Type 2 Diabetes","Adults with newly diagnosed type 2 diabetes mellitus. Participants will undergo clinical evaluation, metabolic phenotyping, imaging assessments, biomarker measurements, gut microbiome profiling from stool samples, and Genetic Risk Score determination.",[25],{"name":26,"affiliation":5,"role":27},"Teresa Mezza","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Teresa Mezza, MD, PhD","CONTACT","+390630156664","teresa.mezza@policlinicogemelli.it",{"type":35,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100644615","exocrine-endocrine-pancreatic-crosstalk-precision-pathways-to-reframe-diabetes-pathophysiology-100644615",false,"NCT07670871","Exocrine-Endocrine Pancreatic Crosstalk: Precision Pathways to Reframe Diabetes Pathophysiology","EXPAND","Inclusion Criteria:\n\n* Adults aged 20 to 78 years.\n* Ability and willingness to provide written informed consent.\n* Eligibility for one of the study cohorts:\n* Individuals undergoing pancreatectomy for non-endocrine pancreatic disease.\n* Individuals with pancreatic ductal adenocarcinoma undergoing pancreatectomy.\n* Individuals with chronic pancreatitis or a previous episode of acute pancreatitis.\n* Individuals at increased risk of type 2 diabetes mellitus, including impaired fasting glucose and\u002For impaired glucose tolerance.\n* Individuals with newly diagnosed type 2 diabetes mellitus.\n* Ability to undergo study-related metabolic assessments and sample collection procedures.\n\nExclusion Criteria:\n\n* Age \\\u003C20 years or \\>78 years.\n* Inability or unwillingness to provide informed consent.\n* Pregnancy or breastfeeding.\n* Diagnosis of type 1 diabetes mellitus.\n* Participation in another interventional clinical trial involving an investigational medicinal product within 30 days before enrollment.\n* Clinical conditions that preclude completion of the planned metabolic assessments.\n* Inability to comply with study procedures.","ALL","20 Years","78 Years",{"count":47,"type":48},440,"ESTIMATED","OBSERVATIONAL","The EXPAND study is a prospective observational study designed to investigate the biological mechanisms underlying the heterogeneity of type 2 diabetes and related metabolic disorders.\n\nThe study will enroll adults with and without pancreatic disease, including patients undergoing pancreatic surgery, individuals with chronic pancreatitis, subjects at high risk of type 2 diabetes, and patients with newly diagnosed type 2 diabetes. Clinical, metabolic, imaging, genetic, microbiome, and molecular data will be integrated to identify distinct metabolic endotypes and to investigate the interactions between the exocrine pancreas, endocrine pancreas, and adipose tissue. The ultimate goal is to improve the understanding of diabetes pathophysiology and support the development of precision medicine approaches.",[52,53,54,55],"Type 2 Diabetes Mellitus (T2DM)","Chronic Pancreatitis","Prediabetes","Pancreatic Neoplasms",[57,58,59,60,61,62,63,64,65,66,67,68,69,70],"Metabolic Endotypes","Beta Cell Function","Insulin Secretion","Insulin Sensitivity","Exocrine Pancreas","Endocrine Pancreas","Pancreatic Crosstalk","Precision Medicine","Glucose Metabolism","Oral Glucose Tolerance Test","Genetic Risk Score","Fat Adipose Tissue","Hyperglycemic Clamp","Microbiome","NOT_YET_RECRUITING","2026-06-22",{"date":74,"type":75},"2026-06-26","ACTUAL",{"date":77,"type":48},"2026-09",{"date":79,"type":48},"2031-09",{"name":5,"class":6}]