A Retrospective Real-World Cohort Study

NCT07781371 | Not Yet Recruiting

• 2 other identifiers: DAS-9012U1111-1341-4025
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Type 2 Diabetes (T2D); Prediabetes; Cardiovascular Disease (CVD); Dyslipidemia; Chronic Kidney Disease (CKD); Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

Outcome Measures

Primary Outcomes (47)

• Index and yearly prevalence of major cardiometabolic diseases (percentage)

  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)

  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)

  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)

  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

  Measured in years

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Age distribution: Number of participants

  Measured as number of participants

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Gender distribution

  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)

  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

  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

  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

  Measured in percentage of events

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Smoking status: percentage of participants

  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)

  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

  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)

  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

  Measured in nanogram (ng)/mL

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of transferrin

  Measured in mg/ deciliter (dL)

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of serum creatinine

  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)

  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)

  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

  Measured in grams (g)/dL

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of albuminuria

  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)

  Measured in mg/g

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of platelets

  Measured in 10\^9 cells/L

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of neutrophils

  Measured in 10\^9 cells/L

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of lymphocytes

  Measured in 10\^9 cells/L

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of monocytes

  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

  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

  Measured in ng/L

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of fasting glucose

  Measured in mg/dL

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of hemoglobin (Hb)

  Measured in g/dL

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of hemoglobin A1c (HbA1c)

  Measured in percentage of total Hb

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of triglycerides

  Measured in mg/dL

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of total cholesterol

  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)

  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)

  Measured in mg/dL

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of lipoprotein A (LpA)

  Measured in mg/dL

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of alanine transaminase (ALT)

  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)

  Measured in U/L

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of FIB-4 score

  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

  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

  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

  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

  Measured in U/L

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of progesterone levels

  Measured in ng/mL

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of estrogen levels

  Measured in picograms (pg)/mL

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

• Laboratory assessment of testosterone levels

  Measured in ng/dL

  Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)

Study Arms (1)

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.

Other: No treatment given

Interventions

No treatment given OTHER

No treatment given

SCALA cohort

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SCALA cohort

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Prediabetic State; Cardiovascular Diseases; Dyslipidemias; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): November 2, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)