Diabetes Mellitus, Type 2TCPT2023NCT06299800
Phenotyping Patients With Type 2 Diabetes Mellitus and Cancer
An observational study of Diabetes Mellitus, Type 2 and Cancer, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Cancer
- What is being tested?
- phenotyping of patients followed at a third-level diabetes centre with cancer
- How many people
- 779 participants
- Where
- 1 siteItaly
- Study dates
- 4 Feb 2024to 4 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 779 patients with diabetes mellitus type 2 and with at least 18 years old.
Who may be able to join
- Legal age
- Diagnosis of type 2 diabetes mellitus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
SCDU Endocrinology, AOU Ospedale Maggiore della Carità
Novara, 28100
Flavia Prodam, +39 0321 660 693, flavia.prodam@med.uniupo.it
About this study
Official title: Type 2 Diabetes Mellitus and Cancer: Phenotyping of Patients at a Third-level Diabetes Centre
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:
Read more
- 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.
Read the 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: Prof.ssa 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:
- Recurrence of cancer (year of onset of recurrence)
- 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, secondary/s, 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 <18.5 Kg/m2), normal weight (BMI 18.5 - 25 Kg/m2), and overweight (BMI >25 Kg/m2).
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;
- Metformin/Acarbosio;
- Sulfanilurea;
- Metformin + GLP1/ DDPIV inhibitors (DDPIVi) or only GLP1 or only DDPIVi;
- Metformin + SGLT2i inhibitors (SGLT2i) or only SGLT2i;
- Basal insulin + GLP1/DDPIVi +/- 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.
- Conditions
- Diabetes Mellitus, Type 2, Cancer
- Being tested
- phenotyping of patients followed at a third-level diabetes centre with cancer
- Keywords
- cancer, diabetes mellitus type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenotyping of patients followed at a third-level diabetes centre with cancerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes mellitus type 2 and cancer | 779 patients with cancer and diagnosis of type 2 diabetes mellitus diagnosed between 1990 and 2010 Receives: Other: phenotyping of patients followed at a third-level diabetes centre with cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking assessment at first visit
identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus: During the first examination, the history of each patient was investigated, evaluating whether they were smokers, non-smokers or ex smokers
Measured: Assessment of data at time 0 (first clinical visit)
Alcool consumption at first visit
identify the risk factors influencing the onset of cancer in the population affected by type 2 diabetes mellitus: During the first examination, the history of each patient was studied, assessing whether I consume alcohol and in what amount. <1 alcohol unit or greater than 2 alcohol units were used as cutoffs to subdivide the patients considered.
Measured: Assessment of data at time 0 (first clinical visit)
BMI assessment at first visit
identify the risk factors influencing the onset of cancer in the population affected by type 2 diabetes mellitus: During the first examination, the history of each patient was studied, measuring weight and height to calculate the BMI of each patient. The ranges considered are: underweight <18.5, normal weight 18.5-25 and overweight >25.
Measured: Assessment of data at time 0 (first clinical visit)
Glycated assessment at first visit
identify the risk factors influencing the onset of cancer in the population affected by type 2 diabetes mellitus: During the first examination, the history of each patient was studied, measuring the glycate of each patient. The considered cutoff is < or equal to 8%, where 8% is the limit for glycemic decompensation.
Measured: Assessment of data at time 0 (first clinical visit)
Secondary outcomes (4)
First-line therapy characteristics assessment at first visit
Detection of drug therapy given at the first visit considering the medical record. The therapies considered were: Dietotherapy, Metformin/Acarbosio, Sulfanilurea, Metformin + GLP1/DDPIVi or GLP1 alone or DDDPIVi alone, Metformin + SGLT2i or SGLT2i alone, Basal insulin + GLP1/DPIVi +/- Metformin, Basal Insulin +/- Metformin + SGT2i, Insulin Basal Bolus, Insulin Basal Bolus +/- Metformin +/- SGLT2i
Measured: Assessment of data at time 0 (first clinical visit)
Primary outcomes and recurrence or presence of a secondary tumor
Considering the risk factors measured as primary findings, it was intended to observe a possible association with those who had recurrence or with the development of a secondary tumour unrelated to the first, within 10 years of the diagnosis of diabetes. Detected during first clinical visit signed in the medical record
Measured: Assessment of data at time 0 (first clinical visit)
Relationship between patients characteristics and the time onset of cancer considering anthropometric and biochemical data
Assess the relationship between the characteristics of patients and the time to the onset of cancer using medical record
Measured: Assessment of data at time 0 (first clinical visit)
Tumour characterization in the considered population, detected at the first clinical visit
Characterization of tumors: tumors of the nervous system, head neck, thoracic, gastrointestinal, gynecological, urological, male genital, cutaneous, haematological, breast, soft tissue, endocrine glands, neuroendocrine and bone tumors. Detected during first clinical visit considering the medical record.
Measured: Assessment of data at time 0 (first clinical visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start4 Feb 2024
- Primary completion4 Feb 2025
- Study completion4 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 779 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della Carita
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flavia Prodam, Azienda Ospedaliero Universitaria Maggiore della Carita
- Investigators
- Flavia Prodam, MD PhD, Principal investigator, AOU Maggiore della Carità di Novara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299800
- Sponsor's protocol ID
- CE385/2023
- Acronym
- TCPT2023
- Status last verified
- Oct 2026
- First submitted
- 13 Feb 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fu Z, Gilbert ER, Liu D. Regulation of insulin synthesis and secretion and pancreatic Beta-cell dysfunction in diabetes. Curr Diabetes Rev. 2013 Jan 1;9(1):25-53.
PubMed 22974359Rojas A, Schneider I, Lindner C, Gonzalez I, Morales MA. Association between diabetes and cancer. Current mechanistic insights into the association and future challenges. Mol Cell Biochem. 2023 Aug;478(8):1743-1758. doi: 10.1007/s11010-022-04630-x. Epub 2022 Dec 24.
PubMed 36565361Cignarelli A, Genchi VA, Caruso I, Natalicchio A, Perrini S, Laviola L, Giorgino F. Diabetes and cancer: Pathophysiological fundamentals of a 'dangerous affair'. Diabetes Res Clin Pract. 2018 Sep;143:378-388. doi: 10.1016/j.diabres.2018.04.002. Epub 2018 Apr 19.
PubMed 29679627Francisco V, Pino J, Campos-Cabaleiro V, Ruiz-Fernandez C, Mera A, Gonzalez-Gay MA, Gomez R, Gualillo O. Obesity, Fat Mass and Immune System: Role for Leptin. Front Physiol. 2018 Jun 1;9:640. doi: 10.3389/fphys.2018.00640. eCollection 2018.
PubMed 29910742Chiefari E, Mirabelli M, La Vignera S, Tanyolac S, Foti DP, Aversa A, Brunetti A. Insulin Resistance and Cancer: In Search for a Causal Link. Int J Mol Sci. 2021 Oct 15;22(20):11137. doi: 10.3390/ijms222011137.
PubMed 34681797Yakar S, Leroith D, Brodt P. The role of the growth hormone/insulin-like growth factor axis in tumor growth and progression: Lessons from animal models. Cytokine Growth Factor Rev. 2005 Aug-Oct;16(4-5):407-20. doi: 10.1016/j.cytogfr.2005.01.010.
PubMed 15886048Mao Z, Zhang W. Role of mTOR in Glucose and Lipid Metabolism. Int J Mol Sci. 2018 Jul 13;19(7):2043. doi: 10.3390/ijms19072043.
PubMed 30011848Saxton RA, Sabatini DM. mTOR Signaling in Growth, Metabolism, and Disease. Cell. 2017 Mar 9;168(6):960-976. doi: 10.1016/j.cell.2017.02.004.
PubMed 28283069Laplante M, Sabatini DM. mTOR signaling in growth control and disease. Cell. 2012 Apr 13;149(2):274-93. doi: 10.1016/j.cell.2012.03.017.
PubMed 22500797Shlomai G, Neel B, LeRoith D, Gallagher EJ. Type 2 Diabetes Mellitus and Cancer: The Role of Pharmacotherapy. J Clin Oncol. 2016 Dec 10;34(35):4261-4269. doi: 10.1200/JCO.2016.67.4044. Epub 2016 Nov 7.
PubMed 27903154Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.
PubMed 29496507
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Mellitus and Cancer: Phenotyping of Patients at a Third-level Diabetes Centre
- ClinicalTrials.gov ID
- NCT06299800
- Acronym / sponsor ID
- TCPT2023 / CE385/2023
- Conditions
- Diabetes Mellitus, Type 2, Cancer
- Keywords
- cancer, diabetes mellitus type 2
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 779 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero Universitaria Maggiore della CaritaUniversity, hospital or other
- Study start
- 4 Feb 2024 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2027 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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: Prof.ssa 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:
- Recurrence of cancer (year of onset of recurrence)
- 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, secondary/s, 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 <18.5 Kg/m2), normal weight (BMI 18.5 - 25 Kg/m2), and overweight (BMI >25 Kg/m2).
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;
- Metformin/Acarbosio;
- Sulfanilurea;
- Metformin + GLP1/ DDPIV inhibitors (DDPIVi) or only GLP1 or only DDPIVi;
- Metformin + SGLT2i inhibitors (SGLT2i) or only SGLT2i;
- Basal insulin + GLP1/DDPIVi +/- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes mellitus type 2 and cancer | – | Other: phenotyping of patients followed at a third-level diabetes centre with cancer779 patients with cancer and diagnosis of type 2 diabetes mellitus diagnosed between 1990 and 2010 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 779 patients with diabetes mellitus type 2 and with at least 18 years old.
Key inclusion criteria (2 listed)
- Legal age
- Diagnosis of type 2 diabetes mellitus
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenotyping of patients followed at a third-level diabetes centre with cancerCollection 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. | Other | Diabetes mellitus type 2 and cancer |
Primary outcome
Smoking assessment at first visit
Time frame: Assessment of data at time 0 (first clinical visit)
identify the risk factors affecting the occurrence of cancer in the population affected by type 2 diabetes mellitus: During the first examination, the history of each patient was investigated, evaluating whether they were smokers, non-smokers or ex smokers
Alcool consumption at first visit
Time frame: Assessment of data at time 0 (first clinical visit)
identify the risk factors influencing the onset of cancer in the population affected by type 2 diabetes mellitus: During the first examination, the history of each patient was studied, assessing whether I consume alcohol and in what amount. <1 alcohol unit or greater than 2 alcohol units were used as cutoffs to subdivide the patients considered.
BMI assessment at first visit
Time frame: Assessment of data at time 0 (first clinical visit)
identify the risk factors influencing the onset of cancer in the population affected by type 2 diabetes mellitus: During the first examination, the history of each patient was studied, measuring weight and height to calculate the BMI of each patient. The ranges considered are: underweight <18.5, normal weight 18.5-25 and overweight >25.
Glycated assessment at first visit
Time frame: Assessment of data at time 0 (first clinical visit)
identify the risk factors influencing the onset of cancer in the population affected by type 2 diabetes mellitus: During the first examination, the history of each patient was studied, measuring the glycate of each patient. The considered cutoff is < or equal to 8%, where 8% is the limit for glycemic decompensation.
4 secondary outcomes
First-line therapy characteristics assessment at first visit
Time frame: Assessment of data at time 0 (first clinical visit)
Primary outcomes and recurrence or presence of a secondary tumor
Time frame: Assessment of data at time 0 (first clinical visit)
Relationship between patients characteristics and the time onset of cancer considering anthropometric and biochemical data
Time frame: Assessment of data at time 0 (first clinical visit)
Tumour characterization in the considered population, detected at the first clinical visit
Time frame: Assessment of data at time 0 (first clinical visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 22974359Fu Z, Gilbert ER, Liu D. Regulation of insulin synthesis and secretion and pancreatic Beta-cell dysfunction in diabetes. Curr Diabetes Rev. 2013 Jan 1;9(1):25-53.
- Background: PubMed 36565361Rojas A, Schneider I, Lindner C, Gonzalez I, Morales MA. Association between diabetes and cancer. Current mechanistic insights into the association and future challenges. Mol Cell Biochem. 2023 Aug;478(8):1743-1758. doi: 10.1007/s11010-022-04630-x. Epub 2022 Dec 24.
- Background: PubMed 29679627Cignarelli A, Genchi VA, Caruso I, Natalicchio A, Perrini S, Laviola L, Giorgino F. Diabetes and cancer: Pathophysiological fundamentals of a 'dangerous affair'. Diabetes Res Clin Pract. 2018 Sep;143:378-388. doi: 10.1016/j.diabres.2018.04.002. Epub 2018 Apr 19.
- Background: PubMed 29910742Francisco V, Pino J, Campos-Cabaleiro V, Ruiz-Fernandez C, Mera A, Gonzalez-Gay MA, Gomez R, Gualillo O. Obesity, Fat Mass and Immune System: Role for Leptin. Front Physiol. 2018 Jun 1;9:640. doi: 10.3389/fphys.2018.00640. eCollection 2018.
- Background: PubMed 34681797Chiefari E, Mirabelli M, La Vignera S, Tanyolac S, Foti DP, Aversa A, Brunetti A. Insulin Resistance and Cancer: In Search for a Causal Link. Int J Mol Sci. 2021 Oct 15;22(20):11137. doi: 10.3390/ijms222011137.
- Background: PubMed 15886048Yakar S, Leroith D, Brodt P. The role of the growth hormone/insulin-like growth factor axis in tumor growth and progression: Lessons from animal models. Cytokine Growth Factor Rev. 2005 Aug-Oct;16(4-5):407-20. doi: 10.1016/j.cytogfr.2005.01.010.
- Background: PubMed 30011848Mao Z, Zhang W. Role of mTOR in Glucose and Lipid Metabolism. Int J Mol Sci. 2018 Jul 13;19(7):2043. doi: 10.3390/ijms19072043.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Flavia Prodam, MD PhD principal investigator
AOU Maggiore della Carità di Novara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Cancer, run by Azienda Ospedaliero Universitaria Maggiore della Carita at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Flavia Prodam, MD PhD (+39 0321 660 693, flavia.prodam@med.uniupo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking assessment at first visit (time frame: Assessment of data at time 0 (first clinical visit)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06299800, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.