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.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Kontakty i lokalizacje
Lokalizacje studiów
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Copenhagen, Dania
- Novo Nordisk Investigational Site
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
SCALA cohort
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: RETROSPECTIVE
Liczba grup / kohort
Kohorty i interwencje
Grupa / KohortaGrupa / Kohorta |
Interwencja / LeczenieInterwencja / Leczenie |
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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 |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Index and yearly prevalence of major cardiometabolic diseases (percentage)
Ramy czasowe: 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
|
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Index and yearly prevalence of major cardiometabolic diseases: binary (yes/no)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Dyrektor Studium: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Choroby układu moczowo-płciowego
- Choroby układu hormonalnego
- Procesy patologiczne
- Zaburzenia odżywiania
- Choroby układu moczowo-płciowego u mężczyzn
- Choroby nerek
- Choroby Urologiczne
- Choroby układu moczowo-płciowego kobiet
- Choroby układu moczowo-płciowego kobiet i powikłania ciąży
- Przewlekła choroba
- Atrybuty choroby
- Choroby metaboliczne
- Przekarmienie
- Masy ciała
- Zaburzenia metabolizmu glukozy
- Cukrzyca
- Niewydolność nerek
- Nadwaga
- Zaburzenia metabolizmu lipidów
- Stany patologiczne, oznaki i objawy
- Choroby żywieniowe i metaboliczne
- Objawy i symptomy
- Otyłość
- Cukrzyca typu 2
- Choroby układu krążenia
- Niewydolność nerek, przewlekła
- Dyslipidemie
- Stan przedcukrzycowy
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- DAS-9012
- U1111-1341-4025 (Inny identyfikator: World Health Organization (WHO))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informacje o lekach i urządzeniach, dokumenty badawcze
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