Clinical trial · Observational
Exocrine-Endocrine Pancreatic Crosstalk: Precision Pathways to Reframe Diabetes Pathophysiology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. The 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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Pancreatitis | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Prediabetes | — | UNRESOLVED | — |
| Type 2 Diabetes Mellitus (T2DM) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (5)
- label
- Pancreatic Surgery for Non-Endocrine Pancreatic Disease
- description
- 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
- Pancreatic Ductal Adenocarcinoma Undergoing Pancreatectomy
- description
- 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
- Chronic or Previous Pancreatitis
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 78 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 20 to 78 years. * Ability and willingness to provide written informed consent. * Eligibility for one of the study cohorts: * Individuals undergoing pancreatectomy for non-endocrine pancreatic disease. * Individuals with pancreatic ductal adenocarcinoma undergoing pancreatectomy. * Individuals with chronic pancreatitis or a previous episode of acute pancreatitis. * Individuals at increased risk of type 2 diabetes mellitus, including impaired fasting glucose and/or impaired glucose tolerance. * Individuals with newly diagnosed type 2 diabetes mellitus. * Ability to undergo study-related metabolic assessments and sample collection procedures. Exclusion Criteria: * Age \<20 years or \>78 years. * Inability or unwillingness to provide informed consent. * Pregnancy or breastfeeding. * Diagnosis of type 1 diabetes mellitus. * Participation in another interventional clinical trial involving an investigational medicinal product within 30 days before enrollment. * Clinical conditions that preclude completion of the planned metabolic assessments. * Inability to comply with study procedures.
References
Publications (0)
Data not yet available