Prediction of Pancreatogenic Diabetes After Partial Resection of the Pancreas

NCT07665710 | Recruiting

• 1 other identifier: PRADO
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to identify clinical, laboratory, imaging, and pathohistological risk factors for the development of pancreatogenic diabetes after partial resection of the pancreas (PRP) and, based on these, to build a predictive model that would enable reliable and accurate identification of patients who will develop pancreatogenic diabetes. A review of the literature shows that there is currently no validated tool available in clinical practice for identifying patients at risk of this type of diabetes after PRP. Etiological differences between type 2 diabetes and pancreatogenic diabetes often lead to late diagnosis, limiting opportunities for timely intervention. The development of a comprehensive predictive model would contribute to a better understanding of the pathophysiology of pancreatogenic diabetes, enable the identification of patients at risk, facilitate tailored clinical monitoring, and allow the implementation of targeted preventive or therapeutic measures in the perioperative period. Based on a review of the literature and clinical observations, the investigators formulated the following hypotheses: H1: Clinical, laboratory, imaging, and pathohistological variables are independently associated with the development of pancreatogenic diabetes after partial pancreatic resection. H2: A predictive model that allows reliable and accurate identification of patients who will develop pancreatogenic diabetes can be build based on the identified variables (H1). H3: A comprehensive predictive model in the perioperative period allows more precise identification of patients who will develop pancreatogenic diabetes, and thus more effective risk stratification compared to the use of individual risk factors (variables). Based on the reviewed literature and our own clinical observations, this constitutes an original contribution to science. The investigators expect that the research will identify key clinical, laboratory, imaging, and pathohistological factors associated with the development of pancreatogenic diabetes after partial pancreatic resection. The development of a clinically useful predictive model that will allow individual risk assessment for the development of pancreatogenic diabetes in patients after partial pancreatic resection is anticipated. A similar comprehensive model has not yet been described in the accessible literature. The research will contribute to a better understanding of metabolic changes and will enable the identification of patients who will develop pancreatogenic diabetes after partial pancreatic resection. The results of the study could provide a basis for improved perioperative monitoring of these patients in the field of pancreatogenic diabetes.

Conditions

Pancreatogenic Diabetes Mellitus

Keywords

Partial Pancreatectomy; Pancreatogenic Diabetes; Prediction Model; Pancreas Volume; C-peptide; HOMA-IR

Outcome Measures

Primary Outcomes (1)

• Development of pancreatogenic diabetes

  Pancreatogenic diabetes will be assessed based on standard diagnostic criteria using oral glucose tolerance test.

  3 months after surgery

Secondary Outcomes (5)

• Insulin Resistance

  Baseline to 3 months after surgery

• Beta Cell Function

  Baseline to 3 months after surgery

• Prediction Model Performance

  At 3 months after surgery

• Patohistology of the Pancreas

  immediately after the resection of the pancreas

• CT of the abdomen

  before the resection of the pancreas and 3 months after the resection

Study Arms (1)

Patients Undergoing Partial Pancreatectomy

This cohort includes adult patients undergoing partial pancreatectomy for various pancreatic diseases. Inclusion criteria: age ≥ 18 years, planned partial resection of the pancreas, absence of known diabetes mellitus, borderline basal glycemia, or impaired glucose tolerance before the procedure, signed written informed consent. Criteria for non-inclusion: known diabetes, borderline basal glycemia or impaired glucose tolerance before surgery (even if confirmed by OGTT before the procedure), inability to provide informed consent. Participants are prospectively followed to assess metabolic changes and the development of pancreatogenic diabetes. No experimental interventions are administered as part of the study; all patients receive standard clinical care. Data collection includes clinical, biochemical, imaging, and histopathological parameters.

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 undergoing partial pancreatectomy for pancreatic diseases at a tertiary care center, which correspond to inclusion and exclusion criteria.

You may qualify if:

• age ≥ 18 years
• planned partial resection of the pancreas
• absence of known diabetes before the procedure
• absence of known borderline basal glycemia before the procedure
• absence of impaired glucose tolerance before the procedure
• signed written informed consent

You may not qualify if:

• known diabetes mellitus before the procedure
• known borderline basal glycemia before the procedure
• impaired glucose tolerance before the procedure
• inability to provide informed consent
• withdrawal of consent during the course of the study
• total resection of the pancreas
• a subsequent decision for conservative treatment (based on clinical characteristics at the time of the surgical procedure)

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

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Study Officials

• Jasna Klen, MD, PhD, Prof.

  Ljubljana University Medical Centre, Zaloška cesta 7, Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brina Šket Tomšič, MD

CONTACT

00 386 1 522 2516; brina.sket@kclj.si

Mojca Lunder, MD, PhD

CONTACT

00 386 1 522 2516; mojca.lunder@kclj.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jasna Klen, MD, PhD, Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 24, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

SL (1)