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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Kontakty a umístění
Studijní místa
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Copenhagen, Dánsko
- Novo Nordisk Investigational Site
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
SCALA cohort
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: RETROSPECTIVE
Počet skupin / kohort
Kohorty a intervence
Skupina / kohortaSkupina / kohorta |
Intervence / LéčbaIntervence / Léčba |
|---|---|
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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 je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Index and yearly prevalence of major cardiometabolic diseases (percentage)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění endokrinního systému
- Patologické procesy
- Poruchy výživy
- Mužská urogenitální onemocnění
- Onemocnění ledvin
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Chronické onemocnění
- Atributy nemoci
- Metabolické choroby
- Nadměrná výživa
- Tělesná hmotnost
- Poruchy metabolismu glukózy
- Diabetes Mellitus
- Renální insuficience
- Nadváha
- Poruchy metabolismu lipidů
- Patologické stavy, příznaky a symptomy
- Nutriční a metabolické nemoci
- Příznaky a symptomy
- Obezita
- Diabetes mellitus, typ 2
- Kardiovaskulární choroby
- Renální insuficience, chronická
- Dyslipidemie
- Prediabetický stav
Další identifikační čísla studie
Další identifikační čísla studie
- DAS-9012
- U1111-1341-4025 (Jiný identifikátor: World Health Organization (WHO))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Informace o lécích a zařízeních, studijní dokumenty
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