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

25. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

100000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Copenhagen, Dänemark
        • Novo Nordisk Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

12 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

SCALA cohort

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: RETROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.

No treatment given

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Index and yearly prevalence of major cardiometabolic diseases (percentage)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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 clearance (CrCl)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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-to-creatinine ratio (ACR)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. August 2026

Primärer Abschluss (Geschätzt)

2. November 2026

Studienabschluss (Geschätzt)

2. November 2026

Studienanmeldedaten

Zuerst eingereicht

19. August 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. August 2026

Zuerst gepostet (Tatsächlich)

24. August 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • DAS-9012
  • U1111-1341-4025 (Andere Kennung: World Health Organization (WHO))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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