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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Teresa Mezza, MD, PhD
- Telefonnummer: +390630156664
- E-post: teresa.mezza@policlinicogemelli.it
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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.
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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.
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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.
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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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Identification and Characterization of Metabolic Endotypes
Tidsram: At baseline and during study assessments up to 60 months
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Identification and characterization of physiological endotypes of glucose metabolism using unsupervised clustering and archetype analysis integrating metabolic phenotyping, imaging, and biological/multi-omic variables.
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At baseline and during study assessments up to 60 months
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Teresa Mezza, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Patologiska processer
- Neoplasmer efter plats
- Neoplasmer
- Kronisk sjukdom
- Sjukdomsegenskaper
- Metaboliska sjukdomar
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Störningar i glukosmetabolism
- Diabetes mellitus
- Neoplasmer i endokrina körtel
- Bukspottkörtelsjukdomar
- Hyperinsulinism
- Mottaglighet för sjukdomar
- Genetisk predisposition för sjukdom
- Patologiska tillstånd, tecken och symtom
- Närings- och metabola sjukdomar
- Pankreatit
- Genetiskt riskpoäng
- Diabetes mellitus, typ 2
- Pankreatiska neoplasmer
- Pankreatit, kronisk
- Insulinresistens
- Prediabetiskt tillstånd
Andra studie-ID-nummer
- 27477
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