Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299800
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-02-13
Brief Title:
Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer
Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Organization:
Azienda Ospedaliero Universitaria Maggiore della Carita
Study Overview
Official Title:
Type 2 Diabetes Mellitus and Cancer Phenotyping of Patients at a Third-level Diabetes Centre
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TCPT2023
Brief 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
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
Detailed Description:
Study design This study is a monocentric retrospective cohort study based on the data available in the Smart Digital Clinic Meteda Srl electronic medical record
Participating centre Surgery of Endocrinology and Diabetology of the SCDU of Novara University of Eastern Piedmont Responsible Profssa Flavia Prodam
Subjects Will be included in the study all patients visited at the Endocrinology and Diabetology surgery of the AOU Major of the Charity of Novara for an initial diagnosis of diabetes mellitus type 2 between 1990 and 2010
Inclusion criteria
Legal age
Diagnosis of type 2 diabetes mellitus Exclusion criteria
Diagnosis of cancer before diagnosis of type 2 diabetes
Diagnosis of diabetes secondary to other diseases
Diagnosis of diabetes secondary to other drugs
Diagnosis of diabetes following surgery
Duration of study 24 months
Follow-up and events of interest Patients included in the study will be followed from the date of diagnosis of type 2 diabetes mellitus until the date of the last available examination
During the follow-up for all patients included the year of onset of the first cancer after the diagnosis of diabetes and the type of tumor will be detected From this information it will be possible to calculate the time between the diagnosis of diabetes and the onset of cancer measured in years
For patients who have developed a first tumor will also be detected
1 Recurrence of cancer year of onset of recurrence
2 Diagnosis of second tumour not related to primary tumour year of onset type of tumour The diagnosis of cancer will be identified through the extraction system from the electronic medical record Smart Digital Clinic Meteda Srl using key words relevant to the area of cancer identified in the section of the medical history The key words will be metastasis adenocarcinoma carcinoma neoplasm secondarys sarcoma tumor adenoma lymphoma leukemia glioma glioblastoma ependymoma basalioma epithelium melanoma mesothelioma cordoma anaplastic differentiated undifferentiated meningioma multiple myeloma small cell carcinoma timoma craniopharyngioma neuroendocrine LH LNH K GIST HCC and NET
Data collection
For each patient the following variables will be extracted from the Smart Digital Clinic electronic medical record for all visits available after diagnosis 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 mellitus 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 mellitus
Treatment of cancer
Family history of cancer The diagnosis of type 2 diabetes mellitus is confirmed at diabetological centres or in some cases by general practitioners who refer patients to specialised diabetological centres The accuracy of the diagnosis will be confirmed by crossing the Piedmont Diabetic Registry PDR and involving a second person to ensure a precise assessment
BMI categories will be divided into underweight BMI 185 Kgm2 normal weight BMI 185 - 25 Kgm2 and overweight BMI 25 Kgm2
With regard to the treatment of type 2 diabetes mellitus participants will be categorised and grouped for statistical purposes in the following classes
Dietary therapy
MetforminAcarbosio
Sulfanilurea
Metformin GLP1 DDPIV inhibitors DDPIVi or only GLP1 or only DDPIVi
Metformin SGLT2i inhibitors SGLT2i or only SGLT2i
Basal insulin GLP1DDPIVi - Metformin
Basal insulin - Metformin - SGLT2i
Insulin basal bolus
Basal insulin bolus - Metformin - SGLT2i In addition complications of metabolic pathology will be extracted from the dedicated section of the program where are systematically recorded and organized and the diagnosis of which is conducted in accordance with the appropriate guidelines These complications will be divided into the following categories vasculopathy neuropathy hypertension heart disease kidney failure and retinopathy
Finally as regards cancer pathology a categorization of treatment will be carried out in three classes chemotherapy surgery and radiation therapy
In addition the types of cancer will be divided in order to ensure greater homogeneity between groups including the nervous system head and neck thorax gastrointestinal gynecological urinary tract male genital system skin blood breast soft tissues endocrine glands and neuroendocrine tumors This information will be collected at the diabetes diagnosis visit and at the last visit before the onset of cancer for the subjects experiencing the event and at the last available visit for the remaining subjects
EXPECTED RESULTS Through this research the investigators aim to obtain new information on the study population in order to better understand the possible correlation between the two pathologies This will allow us to identify the risk factors associated with metabolic pathology that can affect the development time of cancer pathologies as well as to identify those that could contribute to carcinogenesis itself
This knowledge will allow us to define the role of hyperglycemia obesity and other factors or behaviors at risk in the field of cancer in order to act with appropriate prevention strategies thus considering the tumor pathology as one of the possible complications of type 2 diabetes mellitus
Participating centre Surgery of Endocrinology and Diabetology of the SCDU of Novara University of Eastern Piedmont Responsible Profssa Flavia Prodam
Subjects Will be included in the study all patients visited at the Endocrinology and Diabetology surgery of the AOU Major of the Charity of Novara for an initial diagnosis of diabetes mellitus type 2 between 1990 and 2010
Inclusion criteria
Legal age
Diagnosis of type 2 diabetes mellitus Exclusion criteria
Diagnosis of cancer before diagnosis of type 2 diabetes
Diagnosis of diabetes secondary to other diseases
Diagnosis of diabetes secondary to other drugs
Diagnosis of diabetes following surgery
Duration of study 24 months
Follow-up and events of interest Patients included in the study will be followed from the date of diagnosis of type 2 diabetes mellitus until the date of the last available examination
During the follow-up for all patients included the year of onset of the first cancer after the diagnosis of diabetes and the type of tumor will be detected From this information it will be possible to calculate the time between the diagnosis of diabetes and the onset of cancer measured in years
For patients who have developed a first tumor will also be detected
1 Recurrence of cancer year of onset of recurrence
2 Diagnosis of second tumour not related to primary tumour year of onset type of tumour The diagnosis of cancer will be identified through the extraction system from the electronic medical record Smart Digital Clinic Meteda Srl using key words relevant to the area of cancer identified in the section of the medical history The key words will be metastasis adenocarcinoma carcinoma neoplasm secondarys sarcoma tumor adenoma lymphoma leukemia glioma glioblastoma ependymoma basalioma epithelium melanoma mesothelioma cordoma anaplastic differentiated undifferentiated meningioma multiple myeloma small cell carcinoma timoma craniopharyngioma neuroendocrine LH LNH K GIST HCC and NET
Data collection
For each patient the following variables will be extracted from the Smart Digital Clinic electronic medical record for all visits available after diagnosis 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 mellitus 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 mellitus
Treatment of cancer
Family history of cancer The diagnosis of type 2 diabetes mellitus is confirmed at diabetological centres or in some cases by general practitioners who refer patients to specialised diabetological centres The accuracy of the diagnosis will be confirmed by crossing the Piedmont Diabetic Registry PDR and involving a second person to ensure a precise assessment
BMI categories will be divided into underweight BMI 185 Kgm2 normal weight BMI 185 - 25 Kgm2 and overweight BMI 25 Kgm2
With regard to the treatment of type 2 diabetes mellitus participants will be categorised and grouped for statistical purposes in the following classes
Dietary therapy
MetforminAcarbosio
Sulfanilurea
Metformin GLP1 DDPIV inhibitors DDPIVi or only GLP1 or only DDPIVi
Metformin SGLT2i inhibitors SGLT2i or only SGLT2i
Basal insulin GLP1DDPIVi - Metformin
Basal insulin - Metformin - SGLT2i
Insulin basal bolus
Basal insulin bolus - Metformin - SGLT2i In addition complications of metabolic pathology will be extracted from the dedicated section of the program where are systematically recorded and organized and the diagnosis of which is conducted in accordance with the appropriate guidelines These complications will be divided into the following categories vasculopathy neuropathy hypertension heart disease kidney failure and retinopathy
Finally as regards cancer pathology a categorization of treatment will be carried out in three classes chemotherapy surgery and radiation therapy
In addition the types of cancer will be divided in order to ensure greater homogeneity between groups including the nervous system head and neck thorax gastrointestinal gynecological urinary tract male genital system skin blood breast soft tissues endocrine glands and neuroendocrine tumors This information will be collected at the diabetes diagnosis visit and at the last visit before the onset of cancer for the subjects experiencing the event and at the last available visit for the remaining subjects
EXPECTED RESULTS Through this research the investigators aim to obtain new information on the study population in order to better understand the possible correlation between the two pathologies This will allow us to identify the risk factors associated with metabolic pathology that can affect the development time of cancer pathologies as well as to identify those that could contribute to carcinogenesis itself
This knowledge will allow us to define the role of hyperglycemia obesity and other factors or behaviors at risk in the field of cancer in order to act with appropriate prevention strategies thus considering the tumor pathology as one of the possible complications of type 2 diabetes mellitus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None