Metformin and Insulin to Pancreatic Cancer Related Diabetes (Type 3c)

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Description

About 80% of patients with pancreatic adenocarcinoma have aberrant fasting blood glucose at the time of diagnosis. The consistent association between pancreatic cancer and diabetes mellitus has long been recognized and even been termed as "chicken and egg". Many reports have found that pancreatic cancer can result in diabetes, which is called type 3c diabetes. New-onset diabetes is commonly observed in pancreatic cancer patients and has been considered as a potential screening sign. Moreover, diabetes has been found as a predictor of poor outcome in pancreatic cancer.

Pancreatic cancer cells have a strong dependence on glucose and they are well-known for their sweet teeth. High glucose is associated with impaired immunologic reaction, intolerability to chemotherapy, radiotherapy and other major treatments, an increased risk of pancreatic surgery. Given the linkage between pancreatic cancer and diabetes or high blood glucose, a clinical trial is needed to validate the effect of metformin and insulin on regulating blood glucose in type 3c diabetes.

Study Overview

Start Date
August 1, 2022
Completion Date
December 31, 2025
Enrollment
20
Date Posted
March 31, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai 200032, China

Eligibility

Minimum Age (years)
18
Maximum Age (years)
80
Eligibility Criteria
Inclusion Criteria:

Signed informed content obtained prior to treatment
Age ≥ 18 years and ≤ 80 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Patients must have histologically confirmed pancreatic adenocarcinoma
Fasting blood glucose ≥ 7.0 mmol/L(126 mg/dl)
The expected survival after surgery ≥ 3 months

Exclusion Criteria:

Active second primary malignancy or history of second primary malignancy
Patients who have received any form of anti-tumor therapy before surgery, including chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy
Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc
Total bilirubin (TBIL) > institutional upper limit of normal (ULN)
Pregnant or nursing women
Patients who are unwilling or unable to comply with study procedures

Study Contact Info

Study Contact Name
Guopei Luo, M.D., Ph.D.
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05306028