Clinical, Oncologic, and Metabolic Effects of Pancreatic Mass Loss After Pancreatectomy in Non-Diabetic Patients

NCT07608055 | Not Yet Recruiting

• 2 other identifiers: 27340EFSD08-EL25-1419-TM
• Study Type: observational
• Target: 579
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pancreatectomy; Diabetes Mellitus Type 2; Pancreatic Neoplasms

Keywords

Pancreatectomy; New-Onset Diabetes; Pancreatic Surgery; Beta-Cell Function; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

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 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.

You may qualify if:

• Adult patients (≥18 years)
• No diabetes mellitus at baseline
• Undergoing partial, near-total, or total pancreatectomy at the study center
• Availability of clinical and metabolic data according to study component
• Written informed consent for the prospective component

You may not qualify if:

• Diabetes mellitus at baseline
• Age \<18 years
• Missing key clinical data precluding eligibility assessment or primary outcome evaluation
• Refusal or inability to provide informed consent for the prospective component, where applicable

Sponsors & Collaborators

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

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

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.

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 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2037
• Study Completion (Estimated): May 1, 2041
• Last Updated: May 27, 2026

Record last verified: 2026-05

Locations

IT (1)