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

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity and Obesity-related Medical Conditions

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 Type: Observational
• Enrollment (Estimated): 1600

Contacts and Locations

Study Locations

• Russian Federation
  • Ryazan, Russian Federation, 390026
    • Ryazan State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

city of Ryazan

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with adverse cardiovascular outcomes	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	From inclusion in the study to three years

Collaborators and Investigators

• Sponsor: Ryazan State Medical University
• Investigators: Study Director: Alexander N Vorobiev, Candidate of Medical Sciences, Ryazan State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Estimated): December 29, 2027
• Study Completion (Estimated): January 24, 2028

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: January 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 401432

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: the amount of information is determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No