Clinical trial NCT06806371: PREDICTORS of CARDIOVASCULAR OUTCOMES in INDIVIDUALS with DIFFERENT OBESITY PHENOTYPES
Official title: PREDICTORS of CARDIOVASCULAR OUTCOMES in INDIVIDUALS with DIFFERENT OBESITY PHENOTYPES
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity and Obesity-related Medical Conditions
Lead sponsor: Ryazan State Medical University
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 1600
Sex: ALL
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: city of Ryazan

Brief summary: 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?

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Number of participants with adverse cardiovascular outcomes
timeFrame: From inclusion in the study to three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University
Study officials:
affiliation: Ryazan State Medical University
name: Alexander N Vorobiev, Candidate of Medical Sciences
role: STUDY_DIRECTOR
References: