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

19. august 2026 opdateret af: Novo Nordisk A/S

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Danmark
      • Copenhagen, Danmark
        • Novo Nordisk Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

SCALA cohort

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: Ingen behandling givet
Ingen behandling givet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Index and yearly prevalence of major cardiometabolic diseases (percentage)
Tidsramme: 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
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)
Tidsramme: 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)
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)
Tidsramme: 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
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Overlap of major cardiometabolic diseases: binary (yes/no)
Tidsramme: 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)
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Age distribution
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in years
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Age distribution: Number of participants
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured as number of participants
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Gender distribution
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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)
Tidsramme: 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)
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
BMI distribution
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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
Tidsramme: 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 )
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Medical history of interest: percentage of events
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in percentage of events
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Smoking status: percentage of participants
Tidsramme: 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
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Systolic and diastolic blood pressure (BP)
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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)
Tidsramme: 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)
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of ferritin
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in nanogram (ng)/mL
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of transferrin
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/ deciliter (dL)
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of serum creatinine
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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)
Tidsramme: 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)
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of creatinine clearence (CrCl)
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in grams (g)/dL
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of albuminuria
Tidsramme: 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)
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of albumin-tocreatinine ratio (ACR)
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/g
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of platelets
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in 10^9 cells/L
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of neutrophils
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in 10^9 cells/L
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of lymphocytes
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in 10^9 cells/L
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of monocytes
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in ng/L
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of fasting glucose
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of hemoglobin (Hb)
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in g/dL
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of hemoglobin A1c (HbA1c)
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in percentage of total Hb
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of triglycerides
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of total cholesterol
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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)
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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)
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of lipoprotein A (LpA)
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in mg/dL
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of alanine transaminase (ALT)
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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)
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in U/L
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of FIB-4 score
Tidsramme: 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).
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
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in U/L
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of progesterone levels
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in ng/mL
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of estrogen levels
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in picograms (pg)/mL
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Laboratory assessment of testosterone levels
Tidsramme: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Measured in ng/dL
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Efterforskere

  • Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. august 2026

Primær færdiggørelse (Anslået)

2. november 2026

Studieafslutning (Anslået)

2. november 2026

Datoer for studieregistrering

Først indsendt

19. august 2026

Først indsendt, der opfyldte QC-kriterier

19. august 2026

Først opslået (Faktiske)

24. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DAS-9012
  • U1111-1341-4025 (Anden identifikator: World Health Organization (WHO))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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