Pancreatic Cancer and Diabetes Mellitus

June 26, 2025 updated by: Tuo Li, MD, Shanghai Changzheng Hospital

Prospective Cohort Study on Endo-Exdo Secretory Function Alterations and All-round Outcomes After Pancreatic Cancer

The goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.The main questions it aims to answer are:

  1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same?
  2. Are alterations in endocrine and exdocrine secretory function in patients with pancreatic surgery associated with all-round outcomes? All patients with pancreatic surgery have been given the standardized treatment for the condition.

The reasearchers will summarize the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) during different surgical procedures to explore the association between alternations in endocrine and exdocrine secrectory function and all-round outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators will prospectively collect data from patients with pancreatic cancer after surgery in participant centers.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

patients with pancreatic cancer after pancreatic surgery

Description

Inclusion Criteria:

1. male or female Chinese subjects; 2. Age ≥ 18 years; 3. patients with pancreatic cancer who are proposed to undergo pancreatectomy by pancreaticobiliary surgery at our hospital; 4. those who voluntarily completed the Pancreatobiliary Surgery Cohort Study and signed the informed consent; 5. those who have completed and banked serum and pathological specimens at our hospital.

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Exclusion Criteria:

1. those with a previous history of comorbid diabetes mellitus or pre-diabetes mellitus, or preoperative HbA1C ≥ 6.0% or fasting blood glucose ≥ 6.1 mmol/l; 2. those with positive islet-associated antibodies 3. those with the presence of medications, endocrine disease exposures that can lead to a risk of secondary diabetes; 4. pregnant or nursing women; 5. Cognitive impairment or other reasons for failing to sign the informed consent form.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus)
Time Frame: From enrollment to five years after the end of the surgery
The diagnosis of glucose disorders should be made applying criteria of the American Diabetes Association.
From enrollment to five years after the end of the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From enrollment to five years after the end of the surgery
From enrollment to five years after the end of the surgery
Disease-Free Survival
Time Frame: From enrollment to five years after the end of the surgery
From enrollment to five years after the end of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Changzheng Hospital

Investigators

  • Study Director: tuo Li, Prof., Shanghai Changzheng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 2, 2024

First Posted (Actual)

September 5, 2024

Study Record Updates

Last Update Posted (Estimated)

July 1, 2025

Last Update Submitted That Met QC Criteria

June 26, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMU-3CDM-2B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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