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

Study Overview
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Brief Summary
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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.

Official Title
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Administration of Metformin and Insulin to Pancreatic Cancer Related Diabetes Mellitus (Type 3c)

Conditions
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Pancretic Cancer, Diabete Mellitus

Intervention / Treatment
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* Drug: Metformin or insulin treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin or insulin treatment<br> | Drug: Metformin or insulin treatment<br>* 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. For patients with history of diabetes Adjusting metformin or insulin dosage according to the monitor of fasting blood glucose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose control rate | Blood glucose control rate before and after anti-diabetic administration | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C control rate | HbA1C control rate before and after anti-diabetic administration | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood glucose, metformin, insulin