Type 2 Diabetes Mellitus and Cancer: Phenotyping of Patients at a Third-level Diabetes Centre
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 779
- 试验地点
- 1
- 主要终点
- Glycated assessment at first visit
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legal age
- •Diagnosis of type 2 diabetes mellitus
排除标准
- •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
结局指标
主要结局
Glycated assessment at first visit
时间窗: 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.
Smoking assessment at first visit
时间窗: 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
BMI assessment at first visit
时间窗: 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.
Alcool consumption at first visit
时间窗: 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.
次要结局
- Relationship between patients characteristics and the time onset of cancer considering anthropometric and biochemical data(Assessment of data at time 0 (first clinical visit))
- Tumour characterization in the considered population, detected at the first clinical visit(Assessment of data at time 0 (first clinical visit))
- First-line therapy characteristics assessment at first visit(Assessment of data at time 0 (first clinical visit))
- Primary outcomes and recurrence or presence of a secondary tumor(Assessment of data at time 0 (first clinical visit))
研究者
Flavia Prodam
Professor
Azienda Ospedaliero Universitaria Maggiore della Carita