Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus

NCT07607912 | Not Yet Recruiting

• 2 other identifiers: 27417EFSD08-EL25-1419-TM
• Study Type: observational
• Target: 408
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetes Mellitus Type 2; Pancreatectomy; Pancreatic Neoplasms

Keywords

Diabetes Mellitus Type 2; Metabolism; Beta Cells Function; Glycemic Control; Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult patients (≥18 years)
• Diabetes mellitus at baseline
• Undergoing partial, near-total, or total pancreatectomy at the study center for benign or malignant pancreatic disease
• Availability of clinical and metabolic follow-up data according to study component
• Written informed consent for the ambispective and prospective components, where applicable

You may not qualify if:

• Age \<18 years
• Absence of diabetes mellitus at baseline
• Missing essential clinical data or incomplete follow-up precluding evaluation of study outcomes
• Severe pre-existing non-oncologic clinical conditions with life expectancy \<6 months
• Refusal, withdrawal, or inability to provide informed consent for the ambispective and prospective components, where applicable

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead
• European Foundation for the Study of Diabetes: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases

Study Officials

• Teresa Mezza

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Mezza, MD, PhD

CONTACT

06 30156664; teresa.mezza@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 26, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2037
• Study Completion (Estimated): May 1, 2041
• Last Updated: May 26, 2026

Record last verified: 2026-05