A Retrospective Real-World Cohort Study (SCALA-TK-CM)

SCALA-TK-CM: Semaglutide and CArdiometabolic Real-Life Atlas - TürKiye CardioMetabolic Epidemiology Study: 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Dyslipidemia; Prediabetes; Chronic Kidney Disease (CKD); Type 2 Diabetes (T2D); Cardiovascular Disease (CVD); Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
• Intervention / Treatment: Other: No treatment given

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

SCALA cohort

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SCALA cohort; Participants from Acibadem hospital network in Türkiye with index date followed by at least one year of follow-up and the data extraction period spanning from 1 January 2022 to 31 December 2025.	Other: No treatment given; No treatment given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Index and yearly prevalence of major cardiometabolic diseases (percentage)	Measured in 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)	Measured as 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)	Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date. Measured as percentage	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Overlap of major cardiometabolic diseases: binary (yes/no)	Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date. Measured as binary (yes/no)	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Age distribution	Measured in years	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Age distribution: Number of participants	Measured as number of participants	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Gender distribution	Defined as male or female. Measured in percentage	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Gender distribution: binary (yes/no)	Defined as count of male or female. Measured as binary (male/female)	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
BMI distribution	Measured as kilogram (kg)/m^2	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
BMI distribution: number of participants	Measured categorically: number of participants (under 18, 18-25, 25-30, and above 30 kg/m^2 )	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Medical history of interest: percentage of events	Measured in percentage of events	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Smoking status: percentage of participants	Defined by the next categories at index date non-smoker, formal smoker, occasional smoker or current smoker. Measured in percentage of participants	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Systolic and diastolic blood pressure (BP)	Measured in millimeters of mercury (mmHg)	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	Measured in milligram (mg) /Liter (L)	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)	Laboratory assessment of CRP . Measured as 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	Measured in nanogram (ng)/mL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of transferrin	Measured in mg/ deciliter (dL)	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of serum creatinine	Measured in mg/dL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of estimated glomerular filtration rate (eGFR)	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)	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of creatinine clearence (CrCl)	Measured in mL/ minute (min)	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of serum albumin levels	Measured in grams (g)/dL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of albuminuria	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)	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of albumin-tocreatinine ratio (ACR)	Measured in mg/g	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of platelets	Measured in 10^9 cells/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of neutrophils	Measured in 10^9 cells/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of lymphocytes	Measured in 10^9 cells/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of monocytes	Measured in 10^9 cells/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of troponin T (TnT)/high sensitive (hs)-TnT	Measured in ng/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of troponin I (TnI)/high sensitive (hs)-TnI	Measured in ng/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of fasting glucose	Measured in mg/dL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of hemoglobin (Hb)	Measured in g/dL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of hemoglobin A1c (HbA1c)	Measured in percentage of total Hb	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of triglycerides	Measured in mg/dL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of total cholesterol	Measured in mg/dL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of low-density lipoprotein cholesterol (LDL-c)	Measured in mg/dL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of high-density lipoprotein cholesterol (HDL-c)	Measured in mg/dL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of lipoprotein A (LpA)	Measured in mg/dL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of alanine transaminase (ALT)	Measured in unit (U) /L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of aspartate transaminase (AST)	Measured in U/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of FIB-4 score	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).	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	Measured in ng/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of thyroid-stimulating hormone (TSH) levels	Measured in milli-unit (mU)/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of follicle-stimulating hormone (FSH) levels	Measured in U/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of luteinizing hormone (LH) levels	Measured in U/L	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of progesterone levels	Measured in ng/mL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of estrogen levels	Measured in picograms (pg)/mL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of testosterone levels	Measured in ng/dL	Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): November 2, 2026

Study Registration Dates

• First Submitted: August 19, 2026
• First Submitted That Met QC Criteria: August 19, 2026
• First Posted (Actual): August 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 24, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Nutrition Disorders; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Renal Insufficiency; Overweight; Lipid Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Cardiovascular Diseases; Renal Insufficiency, Chronic; Dyslipidemias; Prediabetic State
• Other Study ID Numbers: DAS-9012; U1111-1341-4025 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No