Diabete Mellitus, Pancretic Cancer
Conditions
Keywords
blood glucose, metformin, insulin
Brief summary
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.
Interventions
DRUGMetformin or insulin treatment
1. For patients with new-onset diabetes Fasting blood glucose 7-10 mmol/L, metformin 2 g/day, BID, PO; Fasting blood glucose 10-14 mmol/L, metformin 1 g/day, BID, PO, Novolin 30R Penfil 12 U before breakfast, 8 U; Fasting blood glucose \> 14 mmol/L, metformin 1 g/day, BID, PO, Novolin 30R Penfil 16 U before breakfast, 10 U; Adjusting insulin dosage according to the monitor of fasting blood glucose. 2. For patients with history of diabetes Adjusting metformin or insulin dosage according to the monitor of fasting blood glucose.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 * History of diabetes mellitus, or newly diagnosed diabetes mellitus according to the American Diabetes Association criteria * 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 including surgery, chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency ablation, and molecular targeted therapy * Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc * Pregnant or nursing women * Patients who are unwilling or unable to comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose control rate | 1 week | Blood glucose control rate before and after anti-diabetic administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C control rate | 1 week | HbA1C control rate before and after anti-diabetic administration |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in serum Carbohydrate Antigen 19-9 (CA19-9) From Baseline to Day 8. | 1 week | Change of tumor biomarkers before and after anti-diabetic administration.Patients will collect CA19-9 values on the day of enrollment and on day 8. |
| Overall survival，OS | At the end of Cycle 1 (each cycle is 28 days) | OS of subjects from recruiting to the time of death from any cause |
Countries
China
Outcome results
None listed