A Retrospective Real-World Cohort Study (SCALA-TK-CM)
2026年8月19日 更新者：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.
調査の概要
状態
まだ募集していません
介入・治療
研究の種類
観察的
入学 (推定)
100000
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Novo Nordisk
- 電話番号：(+1) 866-867-7178
- メール：clinicaltrials@novonordisk.com
研究場所
-
-
-
Copenhagen、デンマーク
- Novo Nordisk Investigational Site
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
SCALA cohort
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
治療なし
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Index and yearly prevalence of major cardiometabolic diseases (percentage)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Clinical Transparency (dept. 2834)、Novo Nordisk A/S
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月20日
一次修了 (推定)
2026年11月2日
研究の完了 (推定)
2026年11月2日
試験登録日
最初に提出
2026年8月19日
QC基準を満たした最初の提出物
2026年8月19日
最初の投稿 (実際)
2026年8月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月24日
QC基準を満たした最後の更新が送信されました
2026年8月19日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- DAS-9012
- U1111-1341-4025 (その他の識別子：World Health Organization (WHO))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
医薬品およびデバイス情報、研究文書
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。