Cardiometabolic Risk of Obese Subjects: Cross-sectional Study for the Identification of Genetic, Laboratory and Clinical Determinants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- cycle threshold miRNAs
研究概览
简要总结
experimental study with analysis on tissues. This study aims to study cardiometabolic risk from a genetic, clinical, instrumental and laboratory point of view in a population of subjects with obesity.
详细描述
Compared to normal clinical practice, if you decide to participate in the study you will be asked to:
- allow the collection of an additional study-specific amount of blood as part of a blood sample already provided for by clinical practice during the dietetic visit; The sample will be used to perform the genetic and laboratory analyses required by the study.
- Undergo an additional study-specific visit within one month of the dietetic visit. will be subjected to the measurement of the degree of vascular aging and the evaluation of the health of his/her arteries, through non-invasive examinations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •BMI > 30 Kg/m2
- •In primary prevention for cardiovascular disease
- •Ability to communicate, make themselves understood and adhere to study-specific procedures
- •Willingness to participate in the study and obtain informed consent
排除标准
- •Patients already enrolled by the Research Units involved in the enrolment
- •Glycated hemoglobin level > 55 mmol/L
- •Patients suffering from obesity secondary to endocrinological diseases or iatrogenic causes
- •Patients with heterozygous Familial Hypercholesterolemia (Dutch Lipid Score - DLS>8)
- •Patients suffering from hypercholesterolemia secondary to lipid or iatrogenic extra-metabolic pathologies
- •Patients suffering from systemic inflammatory or oncological diseases
- •Patients on active treatment with GLP-1 analogues
- •Pregnancy and breastfeeding
- •Any medical or surgical condition that makes the patient's adherence to the study protocol complex or inconsistent.
结局指标
主要结局
cycle threshold miRNAs
时间窗: at baseline
Study of the expression profile of specific circulating miRNAs
Presence/absence of the loss-of-function HMGA1 allelic variant (rs146052672)
时间窗: baseline
search for variants of the HMGA1 gene
NGS sequencing of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.
时间窗: baseline
NGS expression of the genes: MC4R, LEP, LEPR, POMC, PCSK1, ADRA2, AGPAT2, HIF1A, HMGA2, HMGB1, INSR, PEPCK, GLUT/SGLT glucose transporters.
Insulinemia (µU/mL)
时间窗: baseline
Levels of haematic insulin
C-peptide (nmol/L)
时间窗: baseline
Levels of haematic of C-peptide
thyrotropin (nmol/L)
时间窗: baseline
Levels of haematic of thyrotropin
HMGA1 protein assay
时间窗: baseline
Levels of haematic HMGA1 protein
次要结局
未报告次要终点