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

Primary Purpose

Pancretic Cancer, Diabete Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Metformin or insulin treatment
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancretic Cancer focused on measuring blood glucose, metformin, insulin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin or insulin treatment

Arm Description

Outcomes

Primary Outcome Measures

Blood glucose control rate
Blood glucose control rate before and after anti-diabetic administration

Secondary Outcome Measures

HbA1C control rate
HbA1C control rate before and after anti-diabetic administration

Full Information

First Posted
March 3, 2022
Last Updated
October 22, 2022
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT05306028
Brief Title
Metformin and Insulin to Pancreatic Cancer Related Diabetes (Type 3c)
Official Title
Administration of Metformin and Insulin to Pancreatic Cancer Related Diabetes Mellitus (Type 3c)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
October 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancretic Cancer, Diabete Mellitus
Keywords
blood glucose, metformin, insulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin or insulin treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin or insulin treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood glucose control rate
Description
Blood glucose control rate before and after anti-diabetic administration
Time Frame
1 week
Secondary Outcome Measure Information:
Title
HbA1C control rate
Description
HbA1C control rate before and after anti-diabetic administration
Time Frame
1 week
Other Pre-specified Outcome Measures:
Title
Change in serum Carbohydrate Antigen 19-9 (CA19-9) From Baseline to Day 8.
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XianJun Yu, M.D., Ph.D.
Phone
+86-21-6417-5590
Email
yuxianjun@fudanpci.org
First Name & Middle Initial & Last Name & Degree
Xianjun Yu, M.D., Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29775599
Citation
Sharma A, Kandlakunta H, Nagpal SJS, Feng Z, Hoos W, Petersen GM, Chari ST. Model to Determine Risk of Pancreatic Cancer in Patients With New-Onset Diabetes. Gastroenterology. 2018 Sep;155(3):730-739.e3. doi: 10.1053/j.gastro.2018.05.023. Epub 2018 Jun 11.
Results Reference
result
PubMed Identifier
19111249
Citation
Pannala R, Basu A, Petersen GM, Chari ST. New-onset diabetes: a potential clue to the early diagnosis of pancreatic cancer. Lancet Oncol. 2009 Jan;10(1):88-95. doi: 10.1016/S1470-2045(08)70337-1.
Results Reference
result
PubMed Identifier
28114552
Citation
Bragg F, Holmes MV, Iona A, Guo Y, Du H, Chen Y, Bian Z, Yang L, Herrington W, Bennett D, Turnbull I, Liu Y, Feng S, Chen J, Clarke R, Collins R, Peto R, Li L, Chen Z; China Kadoorie Biobank Collaborative Group. Association Between Diabetes and Cause-Specific Mortality in Rural and Urban Areas of China. JAMA. 2017 Jan 17;317(3):280-289. doi: 10.1001/jama.2016.19720.
Results Reference
result
PubMed Identifier
25403204
Citation
Yuan C, Rubinson DA, Qian ZR, Wu C, Kraft P, Bao Y, Ogino S, Ng K, Clancy TE, Swanson RS, Gorman MJ, Brais LK, Li T, Stampfer MJ, Hu FB, Giovannucci EL, Kulke MH, Fuchs CS, Wolpin BM. Survival among patients with pancreatic cancer and long-standing or recent-onset diabetes mellitus. J Clin Oncol. 2015 Jan 1;33(1):29-35. doi: 10.1200/JCO.2014.57.5688. Epub 2014 Nov 17.
Results Reference
result

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

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