Retrospective and Prospective Observational Registry for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine-metabolic Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- GLUCOSE
研究概览
简要总结
The main objective of this retrospective and prospective observational register is to identify anthropometric, clinical, laboratory and/or instrumental markers of disease severity and activity in patients suffering from diabetes, endocrine-metabolic disorders, rare diseases in order to improve their diagnosis, monitoring and treatment processes. The Registry is monocentric, observational prospective and retrospective. No additional procedures to those of normal clinical practice are planned, and neither diagnostic approaches nor experimental drugs/prescriptions will be applied. The data under study (demographic, anthropometric, clinical and care characteristics) will be collected as part of outpatient visits of the Diabetes Outpatient Clinic or admission to Diabetes Day Hospital.
In case of outpatients, the observation will start at the diagnosis or during the first outpatient visit and will end with the last outpatient visit performed within the total time foreseen for the duration of the study.
The study will start once the regulatory authorizations are completed, and is expected to last at least 10 years with the possibility of extension
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥18 years
- •Outpatient Diabetes Unit patient
- •Ability to give informed consent
- •Diagnosis of at least one of the following:
- •Metabolic disease, defined as BMI ≥25 Kg/m2
- •Type 1 or type 2 diabetes mellitus
- •Gestational diabetes
- •Monogenic diabetes (MODY)
- •Other types of diabetes or dysglycemia
- •Dyslipidemia
- •Arterial hypertension
- •Steatosis liver disease (SLD)
排除标准
- •Age <18 years
- •Deny participation at the study
- •Recruitment in an interventional protocol
- •Patients with missing significant data
结局指标
主要结局
GLUCOSE
时间窗: baseline
glucose in milligrams per deciliter;
HBA1C
时间窗: baseline
glycates hemoglobin in millimoles per mole.
Insulin
时间窗: baseline
insulin in microunits per milliliter;
UACR
时间窗: baseline
Urine analysis: albumine in milligrams per liter, creatinine millimoles per liter.
Anthropometric parameters
时间窗: baseline
BMI: body mass index : weight/height2 = kilogram/cm2
c-pep
时间窗: baseline
c-peptide in nanograms per milliliter;
次要结局
未报告次要终点
研究者
EMANUELA SETOLA
MEDICAL DOCTOR
IRCCS San Raffaele