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

August 19, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

SCALA cohort

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
No treatment given

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Index and yearly prevalence of major cardiometabolic diseases (percentage)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DAS-9012
  • U1111-1341-4025 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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