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Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer

NCT06299800 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 779

Last updated 2024-03-08

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2
  • Cancer

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.

Sponsors & Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    lead OTHER

Principal Investigators

  • Flavia Prodam, MD PhD · AOU Maggiore della Carità di Novara

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-04
Primary Completion
2025-02-04
Completion
2025-02-04

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06299800 on ClinicalTrials.gov