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

19 августа 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Тип исследования

Наблюдательный

Регистрация (Оцененный)

100000

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

Места учебы

  • Дания
      • Copenhagen, Дания
        • Novo Nordisk Investigational Site

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Ребенок
  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Метод выборки

Невероятностная выборка

Исследуемая популяция

SCALA cohort

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
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.
Другой: Лечение не назначено
Лечение не назначено

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Index and yearly prevalence of major cardiometabolic diseases (percentage)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Novo Nordisk A/S

Следователи

  • Директор по исследованиям: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

20 августа 2026 г.

Первичное завершение (Оцененный)

2 ноября 2026 г.

Завершение исследования (Оцененный)

2 ноября 2026 г.

Даты регистрации исследования

Первый отправленный

19 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

19 августа 2026 г.

Первый опубликованный (Действительный)

24 августа 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

24 августа 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

19 августа 2026 г.

Последняя проверка

1 августа 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • DAS-9012
  • U1111-1341-4025 (Другой идентификатор: World Health Organization (WHO))

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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

Информация о лекарствах и устройствах, исследовательские документы

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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