Pancreatic Cancer and Diabetes Mellitus

NCT06585072 | Recruiting DMC FDA Device

• 1 other identifier: NMU-3CDM-2B
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same?
2. 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.

Conditions

Pancreatic Cancer; Surgery; Diabetes Mellitus

Keywords

Pancreatic Cancer; Surgery; Diabetes Mellitus; Risk factor

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who developed glucose metabolic disorders(pre-diabetes and diabetes mellitus)

  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 Outcomes (2)

• Overall Survival

  From enrollment to five years after the end of the surgery

• Disease-Free Survival

  From enrollment to five years after the end of the surgery

Interventions

All enrolled subjects completed dynamic blood glucose monitoring to obtain continuous peripheral blood glucose data. DIAGNOSTIC_TEST

All enrolled subjects completed dynamic blood glucose monitoring to obtain continuous peripheral blood glucose data.

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

patients with pancreatic cancer after pancreatic surgery

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be collected at every visit

MeSH Terms

Conditions

Pancreatic Neoplasms; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• tuo Li, Prof.

  Shanghai Changzheng Hospital

  STUDY DIRECTOR

Central Study Contacts

Tuo Li, Doctor

CONTACT

86-13918507887; dr.lituo@smmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 5, 2024
• Study Start: January 3, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)