PREDICTORS of CARDIOVASCULAR OUTCOMES in INDIVIDUALS with DIFFERENT OBESITY PHENOTYPES (PRE-CAR)

Ryazan State Medical University

Status: Active, not recruiting

Conditions: Obesity and Obesity-related Medical Conditions

Study type: Observational

Funder types: Other

Identifiers

NCT06806371

401432

Details and patient eligibility

About

The aim of this observational study is to identify and evaluate adverse cardiovascular outcomes in metabolically healthy obese individuals in a cohort of 25 to 64 years of age, both men and women. The main questions it aims to answer are: what are the markers of adverse cardiovascular outcomes in metabolically healthy obese individuals?

Full description

The study is planned to include 1,600 people of the Ryazan city population aged 25-64 years, selected using a three-stage cluster sampling method. Participation in the study is voluntary, as evidenced by the signing of informed consent. Among them, it is planned to select obese people and conduct phenotyping according to the criteria of the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III).

It is planned to conduct a survey at all stages of the study. The questionnaire will include the following modules: social status, dietary habits (dietary habits), physical activity, smoking, alcohol consumption, family history, personal history, objective data, laboratory data, data on medical care and disability, quality of life questionnaire. Measurement of blood pressure, heart rate, height, weight, waist circumference. Laboratory tests: total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, glucose, fibrinogen, uric acid, C-reactive protein (by quantitative method).

Next, it is planned to monitor the examined individuals and collect endpoints for 36 months. The endpoints are: death from any cause, stroke of any etiology, fatal and non-fatal myocardial infarction and coronary artery revascularization, carotid artery surgery. Next, it is planned to establish a relationship between the studied indicators and the frequency of adverse outcomes in individuals with different obesity phenotypes.

Enrollment: 1,600 estimated patients

Sex: All

Ages: 25 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inc1. Body mass index >=30 kg/m2 . 2. Less than three of the five criteria according to The National Cholesterol Education Program's Adult Treatment Panel III, NCEP/ATP III):

• Systolic blood pressure >130 and/or diastolic blood pressure >85 mmHg,
• Triglycerides >1.7 mmol/L,
• High density lipoproteins < 1.03 (men), < 1.29 (women);
• fasting plasma glucose >=5.6 mmol/L,
• waist circumference >102 cm (men), >88 cm (women)lusion Criteria:

Exclusion Criteria:

The presence of

• signs of chronic heart failure,
• coronary heart disease,
• infiltrative or hypertrophic obstructive cardiomyopathy or constrictive pericarditis,
• heart disease or valve disease, which can be expected to lead to surgery during the study,
• cancer.