Ezt az oldalt automatikusan lefordították, és a fordítás pontossága nem garantált. Kérjük, olvassa el a angol verzió forrásszöveghez.

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

2026. augusztus 19. frissítette: 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.

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

100000

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • Dánia
      • Copenhagen, Dánia
        • Novo Nordisk Investigational Site

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Gyermek
  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Mintavételi módszer

Nem valószínűségi minta

Tanulmányi populáció

SCALA cohort

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

Kohorszok és beavatkozások

Csoport / Kohorsz
Beavatkozás / kezelés
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.
Egyéb: Kezelés nem adott
Kezelés nem adott

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Index and yearly prevalence of major cardiometabolic diseases (percentage)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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)
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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
Időkeret: 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)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Novo Nordisk A/S

Nyomozók

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

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. augusztus 20.

Elsődleges befejezés (Becsült)

2026. november 2.

A tanulmány befejezése (Becsült)

2026. november 2.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. augusztus 19.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 19.

Első közzététel (Tényleges)

2026. augusztus 24.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 24.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 19.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • DAS-9012
  • U1111-1341-4025 (Egyéb azonosító: World Health Organization (WHO))

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

IGEN

IPD terv leírása

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

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

Iratkozz fel