NCT06806371

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?

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,600

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2023Jan 2028

Study Start

First participant enrolled

January 9, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2027

Expected
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2028

Last Updated

February 7, 2025

Status Verified

January 1, 2025

Enrollment Period

5 years

First QC Date

January 28, 2025

Last Update Submit

February 4, 2025

Conditions

Obesity and Obesity-related Medical Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age25 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

city of Ryazan

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryazan State Medical University

Ryazan, 390026, Russia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander N Vorobiev, Candidate of Medical Sciences

    Ryazan State Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 4, 2025

Study Start

January 9, 2023

Primary Completion (Estimated)

December 29, 2027

Study Completion (Estimated)

January 24, 2028

Last Updated

February 7, 2025

Record last verified: 2025-01

Locations

RU(1)