Cardiovascular Risk Assessment in a Cohort of Italian Patients With Type 1 Diabetes Mellitus - CARDT1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines.
研究概览
简要总结
This is a multicenter prospective collection of data with diagnostic procedures different from standard clinical care in a specific cohort of patients, aimed to evaluate cardiovascular risk stratification with the European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines and "The Steno Type 1 Risk Engine" algorithm. The correlation between CVD risk, atherosclerosis, and microvascular complications of diabetes (retinopathy, nephropathy, and neuropathy) will then be evaluated, and the impact of glycemic variability and other glucose metrics on vascular damage will be characterized. The investigators plan to enroll at least 200 consecutive type 1 diabetes mellitus (T1DM) patients who meet all the inclusion criteria and none of exclusion criteria.
详细描述
Patients with type 1 diabetes mellitus will be identified in the electronic medical records, and their clinical, anthropometric, and laboratory data, including markers of glycemic variability and other blood glucose metrics, will be collected. Cardiovascular risk will then be assessed using the stratification proposed by ESC/EASD and The Steno Type 1 Risk Engine.
As suggested by the guidelines, according to cardiovascular risk, participants will perform a coronary CT scan in order to investigate coronary anatomy, to study the atherosclerotic plaque morphology, to assess high-risk plaque characteristics, and in case of obstructive coronary artery disease, to investigate myocardial perfusion by adenosine infusion to assess both ischemia and microcirculation dysfunction. Noninvasive B-mode ultrasonography of the supra-aortic trunks will assess for signs of carotid atherosclerosis (i.e., carotid intima media thickness - c-IMT - and carotid plaques). Ankle-arm index (ABI), a noninvasive cardiovascular bio-marker, will provide information on peripheral arterial disease. Endothelial function will be also assessed using the ENDO-PAT 2000 instrument which measures endothelial dysfunction with a peripheral arterial tone detection method.
For the purpose of assessing participants' nutritional habits, participants will be asked to complete the Food Frequency Questionnaire (FFQ) the week prior the visit; once the FFQ will be completed an interview with the nutritionist will be scheduled in order to review and to ascertain its completeness; in addition, the PREDIMED questionnaire for calculating the Mediterranean Diet Adherence Screener score (MEDAS) will be administered to assess adherence to the Mediterranean diet.
An interview with the psychologist will be planned. During that visit the participant will receive information about the rationale of the study regarding psychological aspects, the questionnaires that will be administered and how to fill them out correctly online via the Qualtrics EU platform. The Iowa Gambling Task (IGT) test will then be administered.
Finally, biological samples will be collected for future genomic and epigenetic analyses associated with different cardiovascular disease (CVD) phenotypes and outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Diagnosis of type 1 diabetes mellitus.
- •Age ≥ 18 years.
- •Signed Informed consent
排除标准
- •Age < 18 years.
- •Pregnancy in progress.
- •Type 2 diabetes mellitus.
- •Secondary diabetes
结局指标
主要结局
Stratify cohort of type 1 diabetes patient according to ESC/EASD 2019 guidelines.
时间窗: 5 years
Evaluation of cardiovascular risk class for type 1 diabetic patients using ESC/EASD stratification according to disease duration
Stratify cohort of type 1 diabetes patient according to the Steno Type 1 Risk Engine (ST1RE).
时间窗: 5 years
Evaluation of cardiovascular risk class for type 1 diabetic patients using The Steno Type 1 Risk Engine algorithm
Prevalence of cardiovascular disease in type 1 diabetes patients
时间窗: 5 years
Prevalence of cardiovascular disease in T1DM cohort defined as one of the following: * acute mycardial infarction * ischemic stroke * peripheral artery disease * coronary, carotid or peripheral artery revascularization * presence of clinically significant stenosis in coronary CT and/or in carotid ultrasound assessment.
次要结局
- CT-derived calcium score(5 years)
- Prevalence of diabetic nephropathy(5 years)
- Prevalence of diabetic neuropathy(5 years)
- Stratify type 1 patient cohort by the Mediterranean Diet Adherence Screener score (MEDAS)(At enrollment)
- Stratify type 1 patient cohort by psychological profiles using psychological validated questionnaires.(5 years)
- Stratify type 1 patient cohort by Food Frequency Questionnaire (FFQ)(At enrollment)
- Stratify type 1 patient by glucose control using HbA1c and Ambulatory Glucose Profile metrics.(5 years)
- Prevalence of diabetic retinopathy(5 years)
- Carotid intima-media thickness(5 years)
- Prevalence of endothelial dysfuntion (evaluated using peripheral arterial tone detection method)(5 years)
- Stratify type 1 patient cohort by lipid profile(5 years)