Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy
NCT Number: NCT07608055
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Rome, 00168, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within 12 months after surgery
Incidence of new-onset diabetes mellitus in participants without diabetes at baseline according to the type of pancreatic resection.
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
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
Acronym: DCP-NDM
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