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.
研究概览
研究类型
观察性的
注册 (估计的)
100000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Novo Nordisk
- 电话号码：(+1) 866-867-7178
- 邮箱：clinicaltrials@novonordisk.com
学习地点
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Copenhagen、丹麦
- Novo Nordisk Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
SCALA cohort
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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未给予治疗
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Index and yearly prevalence of major cardiometabolic diseases (percentage)
大体时间：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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Measured in percentage
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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)
大体时间：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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Measured as binary (yes/no)
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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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Overlap of major cardiometabolic diseases (percentage)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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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)
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Overlap of major cardiometabolic diseases: binary (yes/no)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Presence of two or more predefined cardiometabolic conditions documented on or prior to the index date.
Measured as binary (yes/no)
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Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Age distribution
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in years
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Age distribution: Number of participants
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured as number of participants
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Gender distribution
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Defined as male or female.
Measured in percentage
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Gender distribution: binary (yes/no)
大体时间：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)
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BMI distribution
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured as kilogram (kg)/m^2
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Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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BMI distribution: number of participants
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured categorically: number of participants (under 18, 18-25, 25-30, and above 30 kg/m^2 )
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Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Medical history of interest: percentage of events
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in percentage of events
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Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Smoking status: percentage of participants
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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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)
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Systolic and diastolic blood pressure (BP)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in millimeters of mercury (mmHg)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of C reactive protein (CRP)/high sensitive (hs)-CRP
大体时间：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)
|
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Laboratory assessment of CRP/hs-CRP: binary (under and above 2 mg/L)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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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)
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Laboratory assessment of ferritin
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in nanogram (ng)/mL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of transferrin
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mg/ deciliter (dL)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of serum creatinine
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of estimated glomerular filtration rate (eGFR)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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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)
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Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of creatinine clearence (CrCl)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mL/ minute (min)
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of serum albumin levels
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in grams (g)/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of albuminuria
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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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)
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Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of albumin-tocreatinine ratio (ACR)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mg/g
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of platelets
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in 10^9 cells/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of neutrophils
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in 10^9 cells/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of lymphocytes
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in 10^9 cells/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of monocytes
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in 10^9 cells/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of troponin T (TnT)/high sensitive (hs)-TnT
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in ng/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of troponin I (TnI)/high sensitive (hs)-TnI
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in ng/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of fasting glucose
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of hemoglobin (Hb)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in g/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of hemoglobin A1c (HbA1c)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in percentage of total Hb
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of triglycerides
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Laboratory assessment of total cholesterol
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of low-density lipoprotein cholesterol (LDL-c)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of high-density lipoprotein cholesterol (HDL-c)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of lipoprotein A (LpA)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in mg/dL
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of alanine transaminase (ALT)
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in unit (U) /L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of aspartate transaminase (AST)
大体时间：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
大体时间：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)
|
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Laboratory assessment of N-terminal pro-Btype natriuretic peptide (NTproBNP) levels
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in ng/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of thyroid-stimulating hormone (TSH) levels
大体时间：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)
|
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Laboratory assessment of follicle-stimulating hormone (FSH) levels
大体时间：Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
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Measured in U/L
|
Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
|
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Laboratory assessment of luteinizing hormone (LH) levels
大体时间：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
大体时间：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)
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Laboratory assessment of estrogen levels
大体时间：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)
|
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Laboratory assessment of testosterone levels
大体时间：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)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Clinical Transparency (dept. 2834)、Novo Nordisk A/S
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月20日
初级完成 (估计的)
2026年11月2日
研究完成 (估计的)
2026年11月2日
研究注册日期
首次提交
2026年8月19日
首先提交符合 QC 标准的
2026年8月19日
首次发布 (实际的)
2026年8月24日
研究记录更新
最后更新发布 (实际的)
2026年8月24日
上次提交的符合 QC 标准的更新
2026年8月19日
最后验证
2026年8月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- DAS-9012
- U1111-1341-4025 (其他标识符：World Health Organization (WHO))
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
药物和器械信息、研究文件
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.