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RECRUITING
NCT06299800

Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer

Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita

View on ClinicalTrials.gov

Summary

Recent research has highlighted the significant relationship between type 2 diabetes mellitus and cancer, both prevalent and impactful on global health. The intrinsic correlation arises from shared metabolic processes, particularly a systemic and chronic inflammatory state driven by factors like obesity, dyslipidemia, and hyperglycemia. This leads to the creation of a self-sustaining microenvironment known as meta-inflammation, promoting cancer development through DNA damage, oxidative stress, and the influence of hormones like leptin. The hyperglycemic environment in diabetes contributes to cancer development, supporting the Warburg effect and insulin-related mechanisms. This study aims to identify risk factors associated with diabetes that impact tumor development and progression, crucial for guiding effective preventive strategies in clinical practice. Primary objective of the study: \- identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus; Secondary objectives of the study: * description of the demographic, clinical and first-line therapy characteristics of patients diagnosed with type 2 diabetes mellitus; * assess risk factors for recurrence, presence of a second tumour not related to the first and the presence of both events in patients who have had a tumor within 10 years of diagnosis of diabetes; * assess the relationship between the characteristics of patients and the time to the onset of cancer.

Official title: Type 2 Diabetes Mellitus and Cancer: Phenotyping of Patients at a Third-level Diabetes Centre

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

779

Start Date

2024-02-04

Completion Date

2027-02-04

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

OTHER

phenotyping of patients followed at a third-level diabetes centre with cancer

Collection of the following data for each patient enrolled, where possible: * Gender and age; * Smoking habits and alcohol consumption (units per day); * Weight and body mass index (BMI) at first (T0) and last visit (T1); * Given by the diagnosis of type 2 diabetes mellitus; * Treatment of type 2 diabetes at T0 and T1; * Levels of glycated hemoglobin (hba1c) at T0 and T1, mean hba1c and mean fasting blood sugar; * Creatinine clearance at T0 and T1; * Liver enzymes at T0 and T1: alanine aminotransferase (ALT) and aspartate aminotransferase (AST); * T0 and T1 lipid profile: low density lipoproteins (LDL-c) and triglycerides (TG); * Complications of type 2 diabetes; * Treatment of cancer; * Family history of cancer.

Locations (1)

SCDU Endocrinology, AOU Ospedale Maggiore della Carità

Novara, Italy