PREDICTORS of CARDIOVASCULAR OUTCOMES in INDIVIDUALS with DIFFERENT OBESITY PHENOTYPES

Active, not recruiting

• Conditions: Obesity and Obesity-related Medical Conditions

• Registration Number: NCT06806371
• Lead Sponsor: Ryazan State Medical University

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.

Study Timeline

• Study Start: 2023-01-09
• Status Verified: 2025-01
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-01-28
• Study First Posted: 2025-02-04
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2027-12-29
• Study Completion: 2028-01-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse cardiovascular outcomes	From inclusion in the study to three years	The number of people with the following adverse outcomes will be recorded: death from any cause, nonfatal myocardial infarction, nonfatal stroke, coronary artery revascularization, carotid artery surgery

Trial Locations

Locations (1)

Ryazan State Medical University; 🇷🇺 Ryazan, Russian Federation