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NCT Number: NCT07781371

A Retrospective Real-World Cohort Study

The primary objectives are to determine the prevalence and overlap of major cardiometabolic diseases, identify multimorbidity clusters, and characterize demographic, clinical, laboratory, and treatment patterns across the cohort and relevant subgroups. This study is based on anonymized electronic health record (EHR) data and spanning January 2022 to December 2025. EHR will be extracted from participants of Acibadem hospital network in Turkey. Participants received routine clinical care according to physician discretion. Index date will be defined by the first diagnosis of cardiometabolic conditions.

Follow-up period will include at least one year of to allow description of long-term outcomes. It will extend until the end of study, last recorded encounter, or death.

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Key information

Conditions

Obesity Body Weight Cardiovascular Disease (CVD) Cardiovascular Diseases Chronic Disease Chronic Kidney Disease (CKD) Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Dyslipidemia Dyslipidemias Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Lipid Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms PreDiabetes Prediabetic State Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Type 2 Diabetes (T2D) Urogenital Diseases Urologic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants aged above or equal to 12 years at index date.
  • Participants with international classification of diseases (ICD-10) coded diagnosis or secondary criteria for either diabetes (type 2 diabetes, pre-diabetes), overweight, obesity, metabolic dysfunction-associated steatotic liver disease (or non-alcoholic fatty liver disease), cardiovascular disease (arterial hypertension, ischemic heart disease, myocardial infarction, heart failure, cerebrovascular disease (including stroke and transient ischemic attack), atherosclerosis, atrial fibrillation), chronic kidney disease, dyslipidemia.
  • At least one healthcare encounter within 12 months prior to index date (pre-index) to ensure availability of baseline data.

Exclusion criteria

  • None.

Treatment and study plan

No treatment given

Other

No treatment given

Primary outcomes

  1. Index and yearly prevalence of major cardiometabolic diseases (percentage)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year

    Measured in percentage

  2. Index and yearly prevalence of major cardiometabolic diseases: binary (yes/no)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year

    Measured as binary (yes/no)

  3. Overlap of major cardiometabolic diseases (percentage)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date. Measured as percentage

  4. Overlap of major cardiometabolic diseases: binary (yes/no)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date. Measured as binary (yes/no)

  5. Age distribution

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in years

  6. Age distribution: Number of participants

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured as number of participants

  7. Gender distribution

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Defined as male or female. Measured in percentage

  8. Gender distribution: binary (yes/no)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Defined as count of male or female. Measured as binary (male/female)

  9. BMI distribution

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured as kilogram (kg)/m^2

  10. BMI distribution: number of participants

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured categorically: number of participants (under 18, 18-25, 25-30, and above 30 kg/m^2 )

  11. Medical history of interest: percentage of events

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in percentage of events

  12. Smoking status: percentage of participants

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Defined by the next categories at index date non-smoker, formal smoker, occasional smoker or current smoker. Measured in percentage of participants

  13. Systolic and diastolic blood pressure (BP)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in millimeters of mercury (mmHg)

  14. Laboratory assessment of C reactive protein (CRP)/high sensitive (hs)-CRP

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in milligram (mg) /Liter (L)

  15. Laboratory assessment of CRP/hs-CRP: binary (under and above 2 mg/L)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Laboratory assessment of CRP . Measured as binary (under and above 2 mg/L)

  16. Laboratory assessment of ferritin

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in nanogram (ng)/mL

  17. Laboratory assessment of transferrin

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mg/ deciliter (dL)

  18. Laboratory assessment of serum creatinine

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mg/dL

  19. Laboratory assessment of estimated glomerular filtration rate (eGFR)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mL/min/1.73m^2 in categories (under 30 / 30-44 / 45-59 / above or equal to 60 mL/min/1.73m^2)

  20. Laboratory assessment of creatinine clearence (CrCl)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mL/ minute (min)

  21. Laboratory assessment of serum albumin levels

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in grams (g)/dL

  22. Laboratory assessment of albuminuria

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Defined as UACR (urine albumin-to-creatinine ratio) under 30 (A1), above or equal to 30 (A2), or above or equal to 300 mg/g (A3). Measured in mg/g in categories (A1 / A2 / A3)

  23. Laboratory assessment of albumin-tocreatinine ratio (ACR)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mg/g

  24. Laboratory assessment of platelets

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in 10^9 cells/L

  25. Laboratory assessment of neutrophils

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in 10^9 cells/L

  26. Laboratory assessment of lymphocytes

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in 10^9 cells/L

  27. Laboratory assessment of monocytes

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in 10^9 cells/L

  28. Laboratory assessment of troponin T (TnT)/high sensitive (hs)-TnT

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in ng/L

  29. Laboratory assessment of troponin I (TnI)/high sensitive (hs)-TnI

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in ng/L

  30. Laboratory assessment of fasting glucose

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mg/dL

  31. Laboratory assessment of hemoglobin (Hb)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in g/dL

  32. Laboratory assessment of hemoglobin A1c (HbA1c)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in percentage of total Hb

  33. Laboratory assessment of triglycerides

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mg/dL

  34. Laboratory assessment of total cholesterol

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mg/dL

  35. Laboratory assessment of low-density lipoprotein cholesterol (LDL-c)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mg/dL

  36. Laboratory assessment of high-density lipoprotein cholesterol (HDL-c)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mg/dL

  37. Laboratory assessment of lipoprotein A (LpA)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in mg/dL

  38. Laboratory assessment of alanine transaminase (ALT)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in unit (U) /L

  39. Laboratory assessment of aspartate transaminase (AST)

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in U/L

  40. Laboratory assessment of FIB-4 score

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    FIB-4 liver fibrosis score, with previously validated cut-off points to rule in and out the risk of advanced liver fibrosis. FIB-4 score indicating low to high risk ranges from 0.1 (low risk) to 20 (highest risk), where the higher score indicates a higher risk or greater severity of advanced liver fibrosis. Measured categorically as score on the scale (under 1.45, 1.45-2.67, and above 2.67).

  41. Laboratory assessment of N-terminal pro-Btype natriuretic peptide (NTproBNP) levels

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in ng/L

  42. Laboratory assessment of thyroid-stimulating hormone (TSH) levels

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in milli-unit (mU)/L

  43. Laboratory assessment of follicle-stimulating hormone (FSH) levels

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in U/L

  44. Laboratory assessment of luteinizing hormone (LH) levels

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in U/L

  45. Laboratory assessment of progesterone levels

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in ng/mL

  46. Laboratory assessment of estrogen levels

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in picograms (pg)/mL

  47. Laboratory assessment of testosterone levels

    Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

    Measured in ng/dL

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

SCALA-TK-CM: Semaglutide and CArdiometabolic Real-Life Atlas - TürKiye CardioMetabolic Epidemiology Study: A Retrospective Real-World Cohort Study

Acronym: SCALA-TK-CM

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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