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| ID | Type | Description | Link |
|---|---|---|---|
| EFSD08-EL25-1419-TM | Other Grant/Funding Number | European Foundation for the Study of Diabetes (EFSD) |
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| Name | Class |
|---|---|
| European Foundation for the Study of Diabetes | OTHER |
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This study will examine how removal of part or all of the pancreas affects blood sugar control, metabolism, and clinical outcomes over time.
The study will include adults without diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS.
Researchers will study whether participants develop diabetes after surgery and whether this risk changes according to the type of pancreatic resection.
Information from routine clinical care, metabolic tests, imaging, and pancreatic tissue samples collected during surgery may be used for research analyses.
This is a monocentric ambispective observational cohort study conducted at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. The study integrates retrospective, ambispective, and prospective cohorts of patients undergoing partial, near-total, or total pancreatectomy for benign or malignant pancreatic disease.
Pancreatectomy represents a unique human model to investigate the metabolic consequences of acute pancreatic mass loss and beta-cell reduction. However, substantial interindividual variability exists in postoperative glycemic trajectories, suggesting that preoperative metabolic status and tissue-specific factors may contribute to the risk of new-onset diabetes after surgery.
The primary objective is to evaluate the incidence of new-onset diabetes mellitus within 12 months after surgery according to the type of pancreatic resection in patients without diabetes at baseline.
Secondary objectives include longitudinal evaluation of glycemic and metabolic changes after pancreatectomy, assessment of associations between preoperative metabolic characteristics and postoperative glycemic outcomes, exploratory evaluation of pancreatic tissue morphology/molecular characteristics, and analysis of oncologic outcomes including overall survival and disease-free survival.
Clinical, biochemical, radiologic, and metabolic data will be collected according to routine clinical practice. Metabolic evaluations may include OGTT, mixed meal test (MMT), and metabolic clamp procedures when available. Morphological and molecular analyses will be performed on pancreatic tissue obtained from surgical specimens in selected subgroups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Cohort | Prospectively enrolled adult patients without diabetes at baseline undergoing partial, near-total, or total pancreatectomy at the study center. | ||
| Retrospective Cohort | Retrospective cohort of adult patients without diabetes at baseline who underwent pancreatic surgery at the study center. | ||
| Ambispective Cohort | Patients without diabetes at baseline with retrospective baseline data and prospective postoperative follow-up after pancreatic surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of New-Onset Diabetes Mellitus After Pancreatectomy | Incidence of new-onset diabetes mellitus in participants without diabetes at baseline according to the type of pancreatic resection. | Within 12 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients without diabetes at baseline undergoing partial, near-total, or total pancreatectomy according to routine clinical practice for benign or malignant pancreatic diseases at Fondazione Policlinico Universitario Agostino Gemelli IRCCS, including retrospective, ambispective, and prospective study components.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Mezza, MD, PhD | Contact | 06 30156664 | teresa.mezza@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Teresa Mezza | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | 00168 | Italy |
Data sharing plans have not yet been finalized. Any future sharing of de-identified individual participant data will be evaluated in accordance with institutional policies, ethical approvals, participant consent, and applicable data protection regulations.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Pancreatic tissue specimens obtained from surgical resections will be retained for ex vivo morphological and molecular analyses, including transcriptomic and multiomic profiling in selected subgroups.
| D004700 | Endocrine System Diseases |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |