Cardiovascular Disease (CVD), Chronic Kidney Disease (CKD), Dyslipidemia, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Obesity, Prediabetes, Type 2 Diabetes (T2D)
Conditions
Brief summary
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.
Interventions
OTHERNo treatment given
No treatment given
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory assessment of serum albumin levels | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in grams (g)/dL |
| Laboratory assessment of albuminuria | 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) |
| Laboratory assessment of albumin-tocreatinine ratio (ACR) | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in mg/g |
| Laboratory assessment of platelets | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in 10\^9 cells/L |
| Laboratory assessment of neutrophils | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in 10\^9 cells/L |
| Laboratory assessment of lymphocytes | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in 10\^9 cells/L |
| Laboratory assessment of monocytes | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in 10\^9 cells/L |
| Laboratory assessment of troponin T (TnT)/high sensitive (hs)-TnT | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in ng/L |
| Laboratory assessment of troponin I (TnI)/high sensitive (hs)-TnI | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in ng/L |
| Laboratory assessment of fasting glucose | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in mg/dL |
| Laboratory assessment of hemoglobin (Hb) | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in g/dL |
| Laboratory assessment of hemoglobin A1c (HbA1c) | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in percentage of total Hb |
| Laboratory assessment of triglycerides | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in mg/dL |
| Laboratory assessment of total cholesterol | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in mg/dL |
| Laboratory assessment of low-density lipoprotein cholesterol (LDL-c) | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in mg/dL |
| Laboratory assessment of high-density lipoprotein cholesterol (HDL-c) | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in mg/dL |
| Laboratory assessment of lipoprotein A (LpA) | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in mg/dL |
| Laboratory assessment of alanine transaminase (ALT) | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in unit (U) /L |
| Laboratory assessment of aspartate transaminase (AST) | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in U/L |
| Laboratory assessment of FIB-4 score | 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). |
| Laboratory assessment of N-terminal pro-Btype natriuretic peptide (NTproBNP) levels | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in ng/L |
| Laboratory assessment of thyroid-stimulating hormone (TSH) levels | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in milli-unit (mU)/L |
| Laboratory assessment of follicle-stimulating hormone (FSH) levels | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in U/L |
| Laboratory assessment of luteinizing hormone (LH) levels | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in U/L |
| Laboratory assessment of progesterone levels | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in ng/mL |
| Laboratory assessment of estrogen levels | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in picograms (pg)/mL |
| Laboratory assessment of testosterone levels | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in ng/dL |
| Laboratory assessment of estimated glomerular filtration rate (eGFR) | 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) |
| Smoking status: percentage of participants | 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 |
| Systolic and diastolic blood pressure (BP) | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in millimeters of mercury (mmHg) |
| Laboratory assessment of C reactive protein (CRP)/high sensitive (hs)-CRP | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in milligram (mg) /Liter (L) |
| Laboratory assessment of CRP/hs-CRP: binary (under and above 2 mg/L) | 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) |
| Laboratory assessment of ferritin | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in nanogram (ng)/mL |
| Laboratory assessment of transferrin | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in mg/ deciliter (dL) |
| Laboratory assessment of serum creatinine | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in mg/dL |
| Index and yearly prevalence of major cardiometabolic diseases (percentage) | 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 |
| Index and yearly prevalence of major cardiometabolic diseases: 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 | Measured as binary (yes/no) |
| Overlap of major cardiometabolic diseases (percentage) | 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 |
| Overlap of major cardiometabolic diseases: binary (yes/no) | 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) |
| Age distribution | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in years |
| Age distribution: Number of participants | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured as number of participants |
| Gender distribution | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Defined as male or female. Measured in percentage |
| Gender distribution: binary (yes/no) | 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) |
| BMI distribution | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured as kilogram (kg)/m\^2 |
| BMI distribution: number of participants | 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 ) |
| Medical history of interest: percentage of events | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in percentage of events |
| Laboratory assessment of creatinine clearence (CrCl) | Baseline (at index date i.e., between 1 January 2022 to 31 December 2025) | Measured in mL/ minute (min) |
Countries
Denmark
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed