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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 with diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS.
Researchers will study whether glycemic control worsens after surgery and whether this risk changes according to the type of pancreatic resection. The study will also examine changes in glucose metabolism, and cancer-related outcomes.
Information from routine clinical care, metabolic tests, imaging, and pancreatic tissue samples collected during surgery may be used for research analyses.
Pancreatic surgery can lead to substantial changes in glucose metabolism because removal of pancreatic tissue reduces endocrine pancreatic mass and may affect insulin secretion, insulin sensitivity, and hormone regulation. In individuals with preoperative diabetes mellitus, pancreatic resection may further worsen glycemic control, increase treatment requirements, and contribute to heterogeneous metabolic trajectories after surgery.
This monocentric ambispective observational study will evaluate the clinical, metabolic, and oncological consequences of partial, near-total, and total pancreatectomy in adults with preoperative diabetes mellitus undergoing pancreatic surgery at Fondazione Policlinico Universitario A. Gemelli IRCCS.
The primary objective is to assess worsening of glycemic control 12 months after surgery according to the type of pancreatic resection. Secondary objectives include evaluation of longitudinal metabolic changes, diabetes treatment intensification, metabolic phenotypes before surgery, associations between preoperative metabolic characteristics and postoperative outcomes, and exploratory analyses of oncological outcomes including overall survival and disease-free survival.
The study integrates retrospective, ambispective, and prospective cohorts. Data collected as part of routine clinical care may include clinical and surgical information, laboratory data, imaging, oral glucose tolerance tests (OGTT), mixed meal tests (MMT), and metabolic clamp studies when available. Pancreatic tissue obtained from surgical specimens may also be used for histopathological, morphological, and molecular analyses to investigate relationships between pancreatic tissue characteristics, intrapancreatic fat, metabolic phenotypes, and clinical outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Cohort | Prospectively enrolled adult patients with diabetes at baseline undergoing partial, near-total, or total pancreatectomy at the study center. | ||
| Ambispective Cohort | Patients with diabetes at baseline with retrospective baseline data and prospective postoperative follow-up after pancreatic surgery. | ||
| Retrospective Cohort | Retrospective cohort of adult patients with diabetes at baseline who underwent pancreatic surgery at the study center. |
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| Measure | Description | Time Frame |
|---|---|---|
| Worsening of Glycemic Control After Pancreatectomy | Worsening of glycemic control in participants with diabetes at baseline, defined as HbA1c ≥7.0% within 12 months after surgery 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 with diabetes mellitus 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 |
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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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Pancreatic tissue specimens obtained from residual surgical material collected during routine pancreatic surgery may be retained for research analyses. Samples may include formalin-fixed paraffin-embedded (FFPE) tissue, cryopreserved tissue, and isolated pancreatic islets when available. Biospecimens may be used for histopathological, morphological, molecular, transcriptomic, proteomic, lipidomic, and functional analyses related to pancreatic tissue characteristics, intrapancreatic fat, beta-cell function, and metabolic outcomes.
| 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 |
| 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 |
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