Exocrine-Endocrine Pancreatic Crosstalk: Precision Pathways to Reframe Diabetes Pathophysiology (EXPAND)
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Type 2 diabetes mellitus is a heterogeneous disease characterized by substantial variability in pathophysiological mechanisms, disease progression, and clinical outcomes. Current clinical classifications do not fully capture the biological complexity underlying metabolic dysfunction.
The EXPAND (Exocrine-Endocrine Pancreatic Axis in Diabetes) study is a prospective observational study aimed at identifying and characterizing metabolic endotypes through the integration of clinical, metabolic, imaging, genetic, microbiome, and multi-omic data. The study is based on the hypothesis that interactions among the exocrine pancreas, endocrine pancreas, and adipose tissue contribute to beta-cell dysfunction and metabolic heterogeneity.
Approximately 440 participants will be enrolled across five predefined cohorts: patients undergoing pancreatic resection for pancreatic diseases, patients with chronic or previous pancreatitis, individuals at increased risk of type 2 diabetes, and subjects with newly diagnosed type 2 diabetes.
Participants will undergo detailed metabolic phenotyping including oral glucose tolerance tests, hyperglycemic/euglycemic clamp studies, laboratory assessments, magnetic resonance imaging-based body fat quantification, dietary assessment, genetic analyses, microbiome profiling, and biomarker measurements. For surgical cohorts, pancreatic and adipose tissue samples obtained during clinically indicated surgery will also be analyzed.
Unsupervised clustering and archetype analysis approaches will be used to identify metabolic endotypes. Associations between endotypes and clinical, metabolic, imaging, histopathological, genetic, and molecular characteristics will be explored. Longitudinal analyses in surgical cohorts will evaluate metabolic changes following pancreatic resection.
The results are expected to improve the understanding of diabetes pathophysiology and facilitate the development of biomarker-driven precision medicine strategies.
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Teresa Mezza, MD, PhD
- Telefoonnummer: +390630156664
- E-mail: teresa.mezza@policlinicogemelli.it
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
|---|
|
Pancreatic Surgery for Non-Endocrine Pancreatic Disease
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.
|
|
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.
|
|
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.
|
|
Individuals at Risk for Type 2 Diabetes
Adults at increased risk of type 2 diabetes, including individuals with impaired fasting glucose and/or 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.
|
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Identification and Characterization of Metabolic Endotypes
Tijdsspanne: At baseline and during study assessments up to 60 months
|
Identification and characterization of physiological endotypes of glucose metabolism using unsupervised clustering and archetype analysis integrating metabolic phenotyping, imaging, and biological/multi-omic variables.
|
At baseline and during study assessments up to 60 months
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Teresa Mezza, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Endocriene systeemziekten
- Pathologische processen
- Neoplasmata per site
- Neoplasmata
- Chronische ziekte
- Ziekte attributen
- Metabole ziekten
- Neoplasmata van het spijsverteringsstelsel
- Ziekten van het spijsverteringsstelsel
- Glucosemetabolismestoornissen
- Suikerziekte
- Endocriene klierneoplasmata
- Alvleesklier Ziekten
- Hyperinsulinisme
- Ziektegevoeligheid
- Genetische aanleg voor ziekte
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Pancreatitis
- Genetische risicoscore
- Diabetes mellitus, type 2
- Pancreasneoplasmata
- Pancreatitis, chronisch
- Insuline-resistentie
- Prediabetische toestand
Andere studie-ID-nummers
- 27477
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .