CKM Syndrome Prevalence and Its Association With SCORE-2 and BRI
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: No intervention is applied. This is a non-interventional, observational study. Anthropometric measurements and existing laboratory data are used for CKM staging and risk assessment..
- Кому может быть актуально
- Состояния в реестре: Metabolic Syndrome, Cardiovascular Diseases, Chronic Kidney Disease(CKD). Базовые параметры: 30 лет — 79 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Prevalence of Cardiovascular-Kidney-Metabolic (CKM) Syndrome and Its Relationship With SCORE-2 Risk Score and Body Roundness Index (BRI): A Study From Gaziantep, Turkey
Обзор
This cross-sectional study aims to determine the prevalence of Cardiovascular-Kidney-Metabolic (CKM) syndrome in a community-based adult population in Gaziantep, Türkiye. In addition to estimating the prevalence across CKM stages, the study investigates the associations between CKM syndrome and two key risk indicators: the SCORE-2 cardiovascular risk score and Body Roundness Index (BRI). Findings from this study will provide valuable insights into early cardiometabolic risk profiling and support the development of regionally tailored prevention strategies.
Подробное описание
Cardiovascular diseases, diabetes, and chronic kidney diseases are among the leading causes of morbidity and mortality both globally and in Türkiye \[1\]. The Cardiovascular-Kidney-Metabolic (CKM) Syndrome, which defines the shared pathophysiological basis of these conditions, was classified in 2023 by the American Heart Association (AHA) using a stage-based system ranging from 0 to 4 \[1,2\]. This study aims to present, for the first time from Türkiye, community-based prevalence data on CKM Syndrome within the framework of this new definition.
In a large-scale cross-sectional study conducted in the United States by Zhu et al. in 2024 \[3\], CKM stages were found to be associated with social determinants such as education, income, housing, and employment. However, to date, no field study has been conducted in Türkiye based on the AHA's CKM staging system.
This study will also examine the correlation between CKM stages and both the SCORE-2 risk score and the Body Roundness Index (BRI). SCORE-2, developed by the European Society of Cardiology, is a reliable model for estimating 10-year cardiovascular risk based on age, sex, smoking status, systolic blood pressure, total cholesterol, and HDL levels \[4,5\]. BRI is a novel anthropometric parameter that more sensitively reflects abdominal obesity than body mass index (BMI) \[6,7\].
With these objectives, the study will:
Provide the first community-based field data on CKM stages in Türkiye,
Reveal the relationships between CKM stages, SCORE-2, and BRI,
Generate locally relevant findings to inform primary care practices.
By demonstrating the usability of test data already obtained within the scope of the Disease Management Platform (HYP), the study will offer a cost-effective model.
In conclusion, this study will provide pioneering data for both the epidemiological assessment and practical management of CKM syndrome screening in Türkiye.
CKM Staging (Stage 0-4) is defined as follows \[2\]:
Stage 0 - Low Risk Individuals with no identifiable risk factors; considered healthy.
Stage 1 - Early Risk
Presence of at least one metabolic risk factor:
Overweight or obesity (particularly abdominal obesity)
Prediabetes (elevated fasting glucose or HbA1c)
Poor dietary habits and low physical activity
Elevated-normal blood pressure (prehypertension)
Low HDL and/or high triglycerides
Stage 2 - High Risk / Subclinical Disease Individuals with multiple metabolic risk factors but without clinically diagnosed cardiovascular or kidney disease.
Typical combinations in this stage may include:
Dyslipidemia + Prediabetes + Abdominal obesity
Stage 3 - Established Disease
Individuals with a diagnosis of one or more of the following:
Type 2 diabetes
Hypertension
Chronic kidney disease (eGFR \< 60 mL/min/1.73 m²) But who have not yet experienced a major cardiovascular event
Stage 4 - Cardiovascular Outcome
Individuals diagnosed with atherosclerotic cardiovascular disease (ASCVD), including:
Myocardial infarction
Stroke
Peripheral artery disease
Basic Data Required for CKM Staging:
Anthropometric Measurements:
Body Mass Index (BMI), waist circumference, neck circumference, waist-to-height ratio, Body Roundness Index (BRI)
Biochemical Tests:
Fasting glucose, HbA1c, lipid profile (HDL, LDL, total cholesterol, triglycerides), creatinine, estimated glomerular filtration rate (eGFR)
Clinical History:
Presence or absence of diagnosed diabetes, hypertension, or chronic kidney disease
History of major cardiovascular events
Methods Study Design and Setting This is a descriptive, community-based field study to be conducted among individuals registered at the Bağlarbaşı Family Health Center, located in the Şahinbey district of Gaziantep, Türkiye. The primary aim of the study is to determine the prevalence of Cardiovascular-Kidney-Metabolic (CKM) Syndrome stages (Stage 0 to 4) among individuals aged 30 to 79 years, and to evaluate the association of these stages with SCORE-2 risk scores and anthropometric indicators.
Вмешательства
- Другое No intervention is applied. This is a non-interventional, observational study. Anthropometric measurements and existing laboratory data are used for CKM staging and risk assessment.
No intervention is applied. This is a non-interventional, observational study. Anthropometric measurements and existing laboratory data are used for CKM staging and risk assessment.
Первичные конечные точки
- Prevalence of CKM Syndrome stages (0-4) [Срок оценки: At the time of enrollment (single visit)]
Вторичные конечные точки (1)
- Association between CKM stages and SCORE-2 risk scores, BRI [Срок оценки: At the time of enrollment (single visit)]
Критерии участия
Inclusion Criteria Age between 30 and 79 years Residence in Gaziantep, Türkiye
Availability of the following laboratory tests performed within the past 1 month:
Fasting glucose HbA1c Lipid profile (total cholesterol, LDL, HDL, triglycerides) Creatinine Estimated glomerular filtration rate (eGFR) Ability to provide informed consent
Exclusion Criteria Presence of severe physical or mental disability Hospitalization due to acute illness within the past 3 months Pregnancy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Turkey (Türkiye) · 1 центр
- Bağlarbaşı Family Health Center — Gaziantep
Публикации
- Kiremitli T, Kiremitli S, Ulug P, Dinc K, Uzel K, Arslan YK. Are the body shape index, the body roundness index and waist-to-hip ratio better than BMI to predict recurrent pregnancy loss? Reprod Med Biol. 2021 May 21;20(3):327-333. doi: 10.1002/rmb2.12388. eCollection 2021 Jul. PMID 34262401
- Zhang X, Ma N, Lin Q, Chen K, Zheng F, Wu J, Dong X, Niu W. Body Roundness Index and All-Cause Mortality Among US Adults. JAMA Netw Open. 2024 Jun 3;7(6):e2415051. doi: 10.1001/jamanetworkopen.2024.15051. PMID 38837158
- Karakayali M, Pusuroglu H, Altunova M, Yilmaz E, Gullu A. Predictive Value of the SCORE, SCORE2, and Pooled Cohort Risk Equation Systems in Patients with Hypertension. Turk Kardiyol Dern Ars. 2023 Sep;51(6):407-414. doi: 10.5543/tkda.2023.74249. PMID 37671521
- SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021 Jul 1;42(25):2439-2454. doi: 10.1093/eurheartj/ehab309. PMID 34120177
- Zhu R, Wang R, He J, Wang L, Chen H, Niu X, Sun Y, Guan Y, Gong Y, Zhang L, An P, Li K, Ren F, Xu W, Guo J. Prevalence of Cardiovascular-Kidney-Metabolic Syndrome Stages by Social Determinants of Health. JAMA Netw Open. 2024 Nov 4;7(11):e2445309. doi: 10.1001/jamanetworkopen.2024.45309. PMID 39556396
- Ndumele CE, Rangaswami J, Chow SL, Neeland IJ, Tuttle KR, Khan SS, Coresh J, Mathew RO, Baker-Smith CM, Carnethon MR, Despres JP, Ho JE, Joseph JJ, Kernan WN, Khera A, Kosiborod MN, Lekavich CL, Lewis EF, Lo KB, Ozkan B, Palaniappan LP, Patel SS, Pencina MJ, Powell-Wiley TM, Sperling LS, Virani SS, Wright JT, Rajgopal Singh R, Elkind MSV; American Heart Association. Cardiovascular-Kidney-Metabolic PMID 37807924
- Sebastian SA, Padda I, Johal G. Cardiovascular-Kidney-Metabolic (CKM) syndrome: A state-of-the-art review. Curr Probl Cardiol. 2024 Feb;49(2):102344. doi: 10.1016/j.cpcardiol.2023.102344. Epub 2023 Dec 14. PMID 38103820
Идентификаторы
NCT: NCT06944236 · 2025/30