CKM Syndrome Prevalence and Its Association With SCORE-2 and BRI

NCT06944236 | Not Yet Recruiting

• 1 other identifier: 2025/30
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Chronic Kidney Disease(CKD)

Outcome Measures

Primary Outcomes (1)

• Prevalence of CKM Syndrome stages (0-4)

  The proportion of participants classified into CKM Syndrome stages 0 to 4 based on AHA 2023 criteria, using clinical, biochemical, and anthropometric data.

  At the time of enrollment (single visit)

Secondary Outcomes (1)

• Association between CKM stages and SCORE-2 risk scores, BRI

  At the time of enrollment (single visit)

Study Arms (1)

1

All eligible participants aged 30-79 years enrolled from a single family health center in Gaziantep, Türkiye. All participants will undergo anthropometric measurements and be classified into CKM Syndrome stages (0-4) based on clinical and laboratory data. This is a single-group observational study; subgrouping will occur only during analysis.

Other: 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.

Interventions

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. OTHER

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.

1

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This observational study will include individuals aged 30 to 79 years who are registered at Bağlarbaşı Family Health Center, located in the Şahinbey district of Gaziantep, Türkiye. The study population represents a community-based sample receiving routine primary care services. Participants will be selected based on the availability of recent laboratory test results (within the past month) from the national Disease Management Platform (HYP). Anthropometric measurements will be obtained on-site. The population reflects a typical adult primary care population in an urban setting.

You may qualify if:

• 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

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Bağlarbaşı Family Health Center

Gaziantep, 27900, Turkey (Türkiye)

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 Health: A Presidential Advisory From the American Heart Association. Circulation. 2023 Nov 14;148(20):1606-1635. doi: 10.1161/CIR.0000000000001184. Epub 2023 Oct 9. Erratum In: Circulation. 2024 Mar 26;149(13):e1023. doi: 10.1161/CIR.0000000000001241.

  PMID: 37807924 BACKGROUND

• 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 BACKGROUND

Related Links

• AHA

MeSH Terms

Conditions

Metabolic Syndrome; Cardiovascular Diseases; Renal Insufficiency, Chronic

Interventions

Risk Assessment

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Risk Management; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Yıldız Büyükdereli Atadağ, Asst Prof

CONTACT

+903423601200; yildizatadag@gantep.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 25, 2025
• Study Start: June 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)