Diabetes Mellitus Type 2DCP-DMNCT07607912
Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus
An observational study of Diabetes Mellitus Type 2 and Pancreatectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 with 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
- Diabetes Mellitus Type 2, Pancreatectomy, Pancreatic Neoplasms
- How many people
- 408 participants
- Where
- No sites listed yet
- Study dates
- May 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 with diabetes mellitus 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)
- Diabetes mellitus at baseline
- Undergoing partial, near-total, or total pancreatectomy at the study center for benign or malignant pancreatic disease
- Availability of clinical and metabolic follow-up data according to study component
- Written informed consent for the ambispective and prospective components, where applicable
Who cannot join
- Age <18 years
- Absence of diabetes mellitus at baseline
- Missing essential clinical data or incomplete follow-up precluding evaluation of study outcomes
- Severe pre-existing non-oncologic clinical conditions with life expectancy <6 months
- Refusal, withdrawal, or inability to provide informed consent for the ambispective and prospective components, where applicable
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus: 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 with diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS.
Read more
Researchers will study whether glycemic control worsens after surgery and whether this risk changes according to the type of pancreatic resection. The study will also examine changes in glucose metabolism, and cancer-related outcomes.
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
Pancreatic surgery can lead to substantial changes in glucose metabolism because removal of pancreatic tissue reduces endocrine pancreatic mass and may affect insulin secretion, insulin sensitivity, and hormone regulation. In individuals with preoperative diabetes mellitus, pancreatic resection may further worsen glycemic control, increase treatment requirements, and contribute to heterogeneous metabolic trajectories after surgery.
This monocentric ambispective observational study will evaluate the clinical, metabolic, and oncological consequences of partial, near-total, and total pancreatectomy in adults with preoperative diabetes mellitus undergoing pancreatic surgery at Fondazione Policlinico Universitario A. Gemelli IRCCS.
The primary objective is to assess worsening of glycemic control 12 months after surgery according to the type of pancreatic resection. Secondary objectives include evaluation of longitudinal metabolic changes, diabetes treatment intensification, metabolic phenotypes before surgery, associations between preoperative metabolic characteristics and postoperative outcomes, and exploratory analyses of oncological outcomes including overall survival and disease-free survival.
The study integrates retrospective, ambispective, and prospective cohorts. Data collected as part of routine clinical care may include clinical and surgical information, laboratory data, imaging, oral glucose tolerance tests (OGTT), mixed meal tests (MMT), and metabolic clamp studies when available. Pancreatic tissue obtained from surgical specimens may also be used for histopathological, morphological, and molecular analyses to investigate relationships between pancreatic tissue characteristics, intrapancreatic fat, metabolic phenotypes, and clinical outcomes.
- Keywords
- Diabetes Mellitus Type 2, Metabolism, Beta Cells Function, Glycemic Control, Pancreatectomy
- 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 with diabetes at baseline undergoing partial, near-total, or total pancreatectomy at the study center. | |
| Ambispective Cohort | Patients with diabetes at baseline with retrospective baseline data and prospective postoperative follow-up after pancreatic surgery. | |
| Retrospective Cohort | Retrospective cohort of adult patients with diabetes at baseline who underwent pancreatic surgery at the study center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worsening of Glycemic Control After Pancreatectomy
Worsening of glycemic control in participants with diabetes at baseline, defined as HbA1c ≥7.0% within 12 months after surgery according to the type of pancreatic resection.
Measured: Within 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startMay 2026 (estimated)
- 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 Diabetes Mellitus Type 2Studies 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
- 408 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
- NCT07607912
- Sponsor's protocol ID
- 27417
- Other IDs
- EFSD08-EL25-1419-TM
- Acronym
- DCP-DM
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 26 May 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 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Oncological and Metabolic Effects of Pancreatic Mass Loss After Partial, Near-total and Total Pancreatectomy in Patients With Preoperative Diabetes Mellitus: A Monocentric Ambispective Observational Study
- ClinicalTrials.gov ID
- NCT07607912
- Acronym / sponsor ID
- DCP-DM / 27417
- Keywords
- Diabetes Mellitus Type 2, Metabolism, Beta Cells Function, Glycemic Control, Pancreatectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- European Foundation for the Study of Diabetes
- Study start
- May 2026 (estimated)
- Primary completion
- May 2037 (estimated)
- Study completion
- May 2041 (estimated)
- First posted
- 26 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 with diabetes before surgery who undergo pancreatic surgery as part of routine clinical care at Fondazione Policlinico Universitario A. Gemelli IRCCS.
Researchers will study whether glycemic control worsens after surgery and whether this risk changes according to the type of pancreatic resection. The study will also examine changes in glucose metabolism, and cancer-related outcomes.
Information from routine clinical care, metabolic tests, imaging, and pancreatic tissue samples collected during surgery may be used for research analyses.
Detailed description
Pancreatic surgery can lead to substantial changes in glucose metabolism because removal of pancreatic tissue reduces endocrine pancreatic mass and may affect insulin secretion, insulin sensitivity, and hormone regulation. In individuals with preoperative diabetes mellitus, pancreatic resection may further worsen glycemic control, increase treatment requirements, and contribute to heterogeneous metabolic trajectories after surgery.
This monocentric ambispective observational study will evaluate the clinical, metabolic, and oncological consequences of partial, near-total, and total pancreatectomy in adults with preoperative diabetes mellitus undergoing pancreatic surgery at Fondazione Policlinico Universitario A. Gemelli IRCCS.
The primary objective is to assess worsening of glycemic control 12 months after surgery according to the type of pancreatic resection. Secondary objectives include evaluation of longitudinal metabolic changes, diabetes treatment intensification, metabolic phenotypes before surgery, associations between preoperative metabolic characteristics and postoperative outcomes, and exploratory analyses of oncological outcomes including overall survival and disease-free survival.
The study integrates retrospective, ambispective, and prospective cohorts. Data collected as part of routine clinical care may include clinical and surgical information, laboratory data, imaging, oral glucose tolerance tests (OGTT), mixed meal tests (MMT), and metabolic clamp studies when available. Pancreatic tissue obtained from surgical specimens may also be used for histopathological, morphological, and molecular analyses to investigate relationships between pancreatic tissue characteristics, intrapancreatic fat, metabolic phenotypes, and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | –Prospectively enrolled adult patients with diabetes at baseline undergoing partial, near-total, or total pancreatectomy at the study center. |
| Ambispective Cohort | – | –Patients with diabetes at baseline with retrospective baseline data and prospective postoperative follow-up after pancreatic surgery. |
| Retrospective Cohort | – | –Retrospective cohort of adult patients with diabetes at baseline who underwent pancreatic surgery at the study center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diabetes mellitus 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)
- Diabetes mellitus at baseline
- Undergoing partial, near-total, or total pancreatectomy at the study center for benign or malignant pancreatic disease
- Availability of clinical and metabolic follow-up data according to study component
- Written informed consent for the ambispective and prospective components, where applicable
Key exclusion criteria (5 listed)
- Age <18 years
- Absence of diabetes mellitus at baseline
- Missing essential clinical data or incomplete follow-up precluding evaluation of study outcomes
- Severe pre-existing non-oncologic clinical conditions with life expectancy <6 months
- Refusal, withdrawal, or inability to provide informed consent for the ambispective and prospective components, 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
Worsening of Glycemic Control After Pancreatectomy
Time frame: Within 12 months after surgery
Worsening of glycemic control in participants with diabetes at baseline, defined as HbA1c ≥7.0% within 12 months after surgery according to the type of pancreatic resection.
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 26 May 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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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
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus Type 2 and Pancreatectomy, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
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 5 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: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Worsening of Glycemic Control 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 26 May 2026.