NCT07665710 Prediction of Pancreatogenic Diabetes After Partial Resection of the Pancreas
| NCT ID | NCT07665710 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Medical Centre Ljubljana |
| Condition | Pancreatogenic Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-04-01 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Contact & Investigator
Jasna Klen, MD, PhD, Prof.
PRINCIPAL INVESTIGATOR
Ljubljana University Medical Centre, Zaloška cesta 7, Ljubljana
Frequently Asked Questions
Who can join the NCT07665710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatogenic Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07665710 currently recruiting?
Yes, NCT07665710 is actively recruiting participants. Contact the research team at brina.sket@kclj.si for enrollment information.
Where is the NCT07665710 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07665710 clinical trial?
NCT07665710 is sponsored by University Medical Centre Ljubljana. The principal investigator is Jasna Klen, MD, PhD, Prof. at Ljubljana University Medical Centre, Zaloška cesta 7, Ljubljana. The trial plans to enroll 150 participants.
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