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

Registration

Registration

NCT07781371

Acronym

SCALA-TK-CM

Study type

OBSERVATIONAL

Status

ACTIVE_NOT_RECRUITING

Enrollment

100000

Start

2026-08-20

Primary completion

2026-11-02

Lead sponsor

Novo Nordisk A/S

Conditions

Obesity; Type 2 Diabetes (T2D); Prediabetes; Cardiovascular Disease (CVD); Dyslipidemia; Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD); Chronic Kidney Disease (CKD)

Interventions

OTHER:No treatment given

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

OTHER:U1111-1341-4025

Registered primary outcomes

• Index and yearly prevalence of major cardiometabolic diseases (percentage) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year]
• Index and yearly prevalence of major cardiometabolic diseases: binary (yes/no) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025), and at the end of each calendar year]
• Overlap of major cardiometabolic diseases (percentage) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Overlap of major cardiometabolic diseases: binary (yes/no) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Age distribution [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Age distribution: Number of participants [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Gender distribution [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Gender distribution: binary (yes/no) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• BMI distribution [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• BMI distribution: number of participants [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Medical history of interest: percentage of events [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Smoking status: percentage of participants [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Systolic and diastolic blood pressure (BP) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of C reactive protein (CRP)/high sensitive (hs)-CRP [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of CRP/hs-CRP: binary (under and above 2 mg/L) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of ferritin [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of transferrin [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of serum creatinine [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of estimated glomerular filtration rate (eGFR) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of creatinine clearance (CrCl) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of serum albumin levels [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of albuminuria [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of albumin-to-creatinine ratio (ACR) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of platelets [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of neutrophils [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of lymphocytes [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of monocytes [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of troponin T (TnT)/high sensitive (hs)-TnT [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of troponin I (TnI)/high sensitive (hs)-TnI [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of fasting glucose [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of hemoglobin (Hb) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of hemoglobin A1c (HbA1c) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of triglycerides [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of total cholesterol [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of low-density lipoprotein cholesterol (LDL-c) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of high-density lipoprotein cholesterol (HDL-c) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of lipoprotein A (LpA) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of alanine transaminase (ALT) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of aspartate transaminase (AST) [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of FIB-4 score [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of N-terminal pro-Btype natriuretic peptide (NTproBNP) levels [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of thyroid-stimulating hormone (TSH) levels [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of follicle-stimulating hormone (FSH) levels [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of luteinizing hormone (LH) levels [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of progesterone levels [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of estrogen levels [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]
• Laboratory assessment of testosterone levels [Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)]