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

Clinical, Oncologic, and Metabolic Effects of Pancreatic Mass Loss Following Partial, Near-Total, and Total Pancreatectomy in Patients Without Diabetes at Baseline: A Monocentric Ambispective Observational Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07608055

Acronym

DCP-NDM

Enrollment

579

Registered

2026-05-27

Start date

2026-07-20

Completion date

2041-05-01

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Type 2, Pancreatectomy, Pancreatic Neoplasms

Keywords

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

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of New-Onset Diabetes Mellitus After Pancreatectomy	Within 12 months after surgery	Incidence of new-onset diabetes mellitus in participants without diabetes at baseline according to the type of pancreatic resection.

Secondary

Measure	Time frame	Description
To assess the deterioration of glucose metabolism during post-pancreatectomy follow-up	From enrollment to the end of treatment at 12 months	To assess the deterioration of glucose metabolism during post-pancreatectomy follow-up, defined as worsening of glycemic control parameters and/or the initiation or intensification of glucose-lowering therapy in patients without diabetes mellitus at baseline

Countries

Italy

Contacts

CONTACTTeresa Mezza, MD, PhD

teresa.mezza@policlinicogemelli.it06 30156664

PRINCIPAL_INVESTIGATORTeresa Mezza

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome results