Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

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Diabetes Mellitus

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Metformin

Insulin

Insulin, Globin Zinc

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.

Metformin or insulin treatment

Guopei Luo, M.D., Ph.D.

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.

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

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

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.

OS of subjects from recruiting to the time of death from any cause

Blood glucose control rate before and after anti-diabetic administration

HbA1C control rate before and after anti-diabetic administration

Fudan University

Professor

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Chrysarobin

Self-reported and confirmed diabetes (validated by a second source (at least 1), including repeated self-report, contact with physician, linkage to register later point, intake of diabetes medicine, registration of diabetic chiropody, baseline glycated hemoglobin\>=6.0%, five annual blood glucose measurements or two blood glucose measurements per year for five consecutive years) cases were included in the analyses. No information is available to distinguish between type 1 and type 2 diabetes across the population but type 1 is rare by comparison.

Total bicycling is reported in categories of: (0 - reference), (\>0 to \<60), (≤60 to \>150), (≤150 to \< 300) and (≥300) minutes/week

Bicycling

Mathias Ried-Larsen, PhD

The primary aim of the study is to study the relationship between overall bicycling and all-cause mortality and secondarily cardiovascular disease mortality among individuals with diabetes from European countries. A secondary aim will be to study the relation of change in bicycling to all-cause mortality and cardiovascular disease mortality.

AIMS The primary aim of the study is to study the relationship between overall bicycling and all-cause mortality and secondarily cardiovascular disease mortality among individuals with diabetes from European countries. A secondary aim will be to study the relation of change in bicycling to all-cause mortality and cardiovascular disease mortality.

METHODS Study design and setting The study is a nested cohort study in European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. In EPIC, 29 centers in 10 western European countries have collected information on nutrition, lifestyle, anthropometrics and medical history from more than 521 000 study individuals participating in this prospective cohort study. Dietary, medical history and lifestyle were assessed by questionnaires. Blood samples from the participants were taken at the study centers. Baseline (first examination) information was collected 1992-2000 and second examination for exposure has since been obtained at least once in every cohort. Exposure data has subsequently, to the two examinations, been linked to information on vital status and on cause of death were obtained through record linkages with national, regional or local registers, regional health departments, physicians or hospitals, active follow-up or health insurance.

Study population This nested prospective cohort study, sampled individuals with prevalent diabetes in the EPIC cohorts at the baseline assessments in the years 1992-2000. Self-reported and confirmed diabetes (validated by a second source (at least 1), including repeated self-report, contact with physician, linkage to register later point, intake of diabetes medicine, registration of diabetic chiropody, baseline glycated hemoglobin\>=6.0%, five annual blood glucose measurements or two blood glucose measurements per year for five consecutive years) cases were included in the analyses. No information is available to distinguish between type 1 and type 2 diabetes across the population but type 1 is rare by comparison. The nested cohort for this study comprised 12,848 individuals with self-reported and/or confirmed diabetes. Mean (SD) follow-up time was 14.6 (4.8) years. Among the 12,848 prevalent diabetes cases, 5,809 cases were confirmed at baseline as described above.

For further detail, please see the predefined statistical analysis plan (SAP). It can be accessed through the url: http://aktivsundhed.dk/images/docs/SAPMRL.pdf

Bicycling and Mortality Among Individuals With diabetesNutrition (EPIC)

Bicycling and Mortality Among Individuals With Diabetes in the European Prospective Investigation Into Cancer and Nutrition (EPIC)

Request for individual patient data should be directed to the International Agency for Research on Cancer (IARC)

The predefined statistical analyses plan is available (see link)

0 (Alive at follow-up) or 1 (Death at follow-up: cause being International Classification of Diseases, Injuries, and Causes of Death, Tenth Revision, I00-I99 )

0 (Alive at follow-up) or 1 (Death at follow-up)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metformin and Insulin to Pancreatic Cancer Related Diabetes (Type 3c)	NCT05306028	Pancretic Cance... Diabete Mellitu...	Metformin or in...	18 Years - 80 Years	Fudan University
Metformin and Insulin to Pancreatic Cancer Related Diabetes (Type 3c)	NCT05306028	Pancretic Cance... Diabete Mellitu...	Metformin or in...	18 Years - 80 Years	Fudan University
Bicycling and Mortality Among Individuals With diabetesNutrition (EPIC)	NCT04171557	Diabete Mellitu...	Bicycling	20 Years -	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for diabete mellitus