PancreatectomyDCP-NDMNCT07608055
Clinical, Oncologic, and Metabolic Effects of Pancreatic Mass Loss After Pancreatectomy in Non-Diabetic Patients
An observational study of Pancreatectomy and Diabetes Mellitus Type 2, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatectomy, Diabetes Mellitus Type 2, Pancreatic Neoplasms
- How many people
- 579 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jul 2026to May 2041
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
Teresa Mezza, MD, PhD, 0630156664, teresa.mezza@policlinicogemelli.it
About this study
Official title: 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
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.
Read the 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.
- Keywords
- Pancreatectomy, New-Onset Diabetes, Pancreatic Surgery, Beta-Cell Function, type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months after surgery
Secondary outcomes (1)
To assess the deterioration of glucose metabolism during post-pancreatectomy follow-up
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
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start20 Jul 2026
- Primary completionMay 2037 (estimated)
- Study completionMay 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatectomyStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 579 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes
- Responsible party
- Sponsor
- Investigators
- Teresa Mezza, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608055
- Sponsor's protocol ID
- 27340
- Other IDs
- EFSD08-EL25-1419-TM
- Acronym
- DCP-NDM
- Status last verified
- Sep 2026
- First submitted
- 21 May 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing plans have not yet been finalized. Any future sharing of de-identified individual participant data will be evaluated in accordance with institutional policies, ethical approvals, participant consent, and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07608055
- Acronym / sponsor ID
- DCP-NDM / 27340
- Keywords
- Pancreatectomy, New-Onset Diabetes, Pancreatic Surgery, Beta-Cell Function, type 2 diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 579 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- May 2037 (estimated)
- Study completion
- May 2041 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of New-Onset Diabetes Mellitus After Pancreatectomy
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.
1 secondary outcome
To assess the deterioration of glucose metabolism during post-pancreatectomy follow-up
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Undecided. Data sharing plans have not yet been finalized. Any future sharing of de-identified individual participant data will be evaluated in accordance with institutional policies, ethical approvals, participant consent, and applicable data protection regulations.
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Pancreatic Diseases
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Teresa Mezza principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatectomy and Diabetes Mellitus Type 2, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Mezza, MD, PhD (06 30156664, teresa.mezza@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of New-Onset Diabetes Mellitus After Pancreatectomy (time frame: Within 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.