Type 2 Diabetes Mellitus (T2DM)EXPANDNCT07670871
Exocrine-Endocrine Pancreatic Crosstalk: Precision Pathways to Reframe Diabetes Pathophysiology
An observational study of Type 2 Diabetes Mellitus (T2DM) and Chronic Pancreatitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 78 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Chronic Pancreatitis, Prediabetes
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Keywords
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2, Pancreatitis, Chronic, Prediabetic State, Pancreatic Neoplasms, Insulin Resistance, Genetic Risk Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and during study assessments up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa Mezza, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670871
- Sponsor's protocol ID
- 27477
- Acronym
- EXPAND
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exocrine-Endocrine Pancreatic Crosstalk: Precision Pathways to Reframe Diabetes Pathophysiology
- ClinicalTrials.gov ID
- NCT07670871
- Acronym / sponsor ID
- EXPAND / 27477
- Keywords
- Metabolic Endotypes, Beta Cell Function, Insulin Secretion, Insulin Sensitivity, Exocrine Pancreas, Endocrine Pancreas, Pancreatic Crosstalk, Precision Medicine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification and Characterization of Metabolic Endotypes
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teresa Mezza principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus (T2DM) and Chronic Pancreatitis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Mezza, MD, PhD (+390630156664, teresa.mezza@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and Characterization of Metabolic Endotypes (time frame: At baseline and during study assessments up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.