Obesity and Obesity-related Medical ConditionsPRE-CARNCT06806371
PREDICTORS of CARDIOVASCULAR OUTCOMES in INDIVIDUALS with DIFFERENT OBESITY PHENOTYPES
An observational study of Obesity and Obesity-related Medical Conditions, run by Ryazan State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 64 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- How many people
- 1,600 participants
- Where
- 1 siteRussia
- Study dates
- 9 Jan 2023to 24 Jan 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: city of Ryazan
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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.
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From inclusion in the study to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start9 Jan 2023
- Primary completion29 Dec 2027 (estimated)
- Study completion24 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander N Vorobiev, Candidate of Medical Sciences, Study director, Ryazan State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806371
- Sponsor's protocol ID
- 401432
- Acronym
- PRE-CAR
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: the amount of information is determined
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICTORS of CARDIOVASCULAR OUTCOMES in INDIVIDUALS with DIFFERENT OBESITY PHENOTYPES
- ClinicalTrials.gov ID
- NCT06806371
- Acronym / sponsor ID
- PRE-CAR / 401432
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 29 Dec 2027 (estimated)
- Study completion
- 24 Jan 2028 (estimated)
- First posted
- 4 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 25 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- city of Ryazan
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with adverse cardiovascular outcomes
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: Undecided. the amount of information is determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander N Vorobiev, Candidate of Medical Sciences study director
Ryazan State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Obesity-related Medical Conditions, run by Ryazan State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse cardiovascular outcomes (time frame: From inclusion in the study to three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.