Exocrine-Endocrine Pancreatic Crosstalk: Precision Pathways to Reframe Diabetes Pathophysiology

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-78
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 20 to 78 years.

Ability and willingness to provide written informed consent.

Individuals undergoing pancreatectomy for non-endocrine pancreatic disease.

Individuals with pancreatic ductal adenocarcinoma undergoing pancreatectomy.

Disqualifiers

Age <20 years or >78 years.

Inability or unwillingness to provide informed consent.

Pregnancy or breastfeeding.

Diagnosis of type 1 diabetes mellitus.

Trial population

Participants will be recruited from patients receiving care at Fondazione Policlinico Universitario A. Gemelli IRCCS (Rome, Italy). The study population includes adults with and without pancreatic disease, including individuals undergoing pancreatic resection, patients with chronic or previous pancreatitis, subjects at increased risk of type 2 diabetes mellitus, and individuals with newly diagnosed type 2 diabetes mellitus. Participants will be consecutively enrolled from the Departments of Endocrinology, Diabetology, Gastroenterology, and Pancreatic Surgery according to the predefined eligibility criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

440 Participants
are grouped into 5 trial groups
Group A: Pancreatic Surgery for Non-Endocrine Pancreatic Disease
Group B: Pancreatic Ductal Adenocarcinoma Undergoing Pancreatectomy
Group C: Chronic or Previous Pancreatitis
Group D: Individuals at Risk for Type 2 Diabetes
Group E: Newly Diagnosed Type 2 Diabetes

Trial outcomes

Primary outcomes

1

Identification and Characterization of Metabolic Endotypes

Identification and characterization of physiological endotypes of glucose metabolism using unsupervised clustering and archetype analysis integrating metabolic phenotyping, imaging, and biological/multi-omic variables.

Time frame
At baseline and during study assessments up to 60 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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