ClinicalTrials.gg
Active, not recruitingNCT07781371SCALA-TK-CMUpdated Sep 30, 2026

A Retrospective Real-World Cohort Study

An observational study in Obesity, Type 2 Diabetes (T2D) and Prediabetes, sponsored by Novo Nordisk A/S. Active, not recruiting at 1 site in Denmark. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Novo Nordisk A/S · Observational

Updated Sep 30, 2026Now Active, not recruitingPrimary outcomes revisedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100,000
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Type 2 Diabetes (T2D)
  • Prediabetes
  • Cardiovascular Disease (CVD)
  • Dyslipidemia
  • Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
  • Chronic Kidney Disease (CKD)
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 114 across 2,154 observational studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

SCALA cohort

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ), 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

Exclusion Criteria:

  • None.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNo treatment given

    No treatment given

06

What researchers measure

Primary outcomes

  1. Index and yearly prevalence of major cardiometabolic diseases (percentage)

    Measured in 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

  2. Index and yearly prevalence of major cardiometabolic diseases: binary (yes/no)

    Measured as 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

  3. 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

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

  4. 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)

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

  5. Age distribution

    Measured in years

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

  6. Age distribution: Number of participants

    Measured as number of participants

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

  7. Gender distribution

    Defined as male or female. Measured in percentage

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

  8. Gender distribution: binary (yes/no)

    Defined as count of male or female. Measured as binary (male/female)

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

  9. BMI distribution

    Measured as kilogram (kg)/m\^2

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

  10. BMI distribution: number of participants

    Measured categorically: number of participants (under 18, 18-25, 25-30, and above 30 kg/m\^2 )

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

  11. Medical history of interest: percentage of events

    Measured in percentage of events

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

  12. 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

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

  13. Systolic and diastolic blood pressure (BP)

    Measured in millimeters of mercury (mmHg)

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

  14. Laboratory assessment of C reactive protein (CRP)/high sensitive (hs)-CRP

    Measured in milligram (mg) /Liter (L)

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

  15. 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)

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

  16. Laboratory assessment of ferritin

    Measured in nanogram (ng)/mL

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

  17. Laboratory assessment of transferrin

    Measured in mg/ deciliter (dL)

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

  18. Laboratory assessment of serum creatinine

    Measured in mg/dL

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

  19. 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)

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

  20. Laboratory assessment of creatinine clearance (CrCl)

    Measured in mL/ minute (min)

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

  21. Laboratory assessment of serum albumin levels

    Measured in grams (g)/dL

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

  22. 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)

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

  23. Laboratory assessment of albumin-to-creatinine ratio (ACR)

    Measured in mg/g

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

  24. Laboratory assessment of platelets

    Measured in 10\^9 cells/L

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

  25. Laboratory assessment of neutrophils

    Measured in 10\^9 cells/L

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

  26. Laboratory assessment of lymphocytes

    Measured in 10\^9 cells/L

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

  27. Laboratory assessment of monocytes

    Measured in 10\^9 cells/L

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

  28. Laboratory assessment of troponin T (TnT)/high sensitive (hs)-TnT

    Measured in ng/L

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

  29. Laboratory assessment of troponin I (TnI)/high sensitive (hs)-TnI

    Measured in ng/L

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

  30. Laboratory assessment of fasting glucose

    Measured in mg/dL

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

  31. Laboratory assessment of hemoglobin (Hb)

    Measured in g/dL

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

  32. Laboratory assessment of hemoglobin A1c (HbA1c)

    Measured in percentage of total Hb

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

  33. Laboratory assessment of triglycerides

    Measured in mg/dL

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

  34. Laboratory assessment of total cholesterol

    Measured in mg/dL

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

  35. Laboratory assessment of low-density lipoprotein cholesterol (LDL-c)

    Measured in mg/dL

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

  36. Laboratory assessment of high-density lipoprotein cholesterol (HDL-c)

    Measured in mg/dL

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

  37. Laboratory assessment of lipoprotein A (LpA)

    Measured in mg/dL

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

  38. Laboratory assessment of alanine transaminase (ALT)

    Measured in unit (U) /L

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

  39. Laboratory assessment of aspartate transaminase (AST)

    Measured in U/L

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

  40. 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).

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

  41. Laboratory assessment of N-terminal pro-Btype natriuretic peptide (NTproBNP) levels

    Measured in ng/L

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

  42. Laboratory assessment of thyroid-stimulating hormone (TSH) levels

    Measured in milli-unit (mU)/L

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

  43. Laboratory assessment of follicle-stimulating hormone (FSH) levels

    Measured in U/L

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

  44. Laboratory assessment of luteinizing hormone (LH) levels

    Measured in U/L

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

  45. Laboratory assessment of progesterone levels

    Measured in ng/mL

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

  46. Laboratory assessment of estrogen levels

    Measured in picograms (pg)/mL

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

  47. Laboratory assessment of testosterone levels

    Measured in ng/dL

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

07

Study locations

1 site
  • Novo Nordisk Investigational Site
    Copenhagen, Denmark
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2026 (actual). Primary completion is estimated for Nov 2026, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Aug 24, 2026
StartActual
Aug 20, 2026
Primary completionEst.
Nov 2, 2026
CompletionEst.
Nov 2, 2026
Last update
Sep 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Active, not recruiting
changed Sep 30, 2026
Primary outcomes
2 edited
What changed in the outcomes
  • EditedLaboratory assessment of creatinine clearenceclearance (CrCl)Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
  • EditedLaboratory assessment of albumin-tocreatinineto-creatinine ratio (ACR)Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Not yet recruiting→Active, not recruiting
    Primary outcomes 2 edited
    What changed in the outcomes
    • EditedLaboratory assessment of creatinine clearenceclearance (CrCl)Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
    • EditedLaboratory assessment of albumin-tocreatinineto-creatinine ratio (ACR)Time frame: Baseline (at index date i.e., between 1 January 2022 to 31 December 2025)
    + 3 other changes: verification date, date precision and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07781371
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Aug 20, 2026
Primary completion
Nov 2, 2026 (estimated)
Completion
Nov 2, 2026 (estimated)
Last update
Sep 30, 2026

Study contacts

Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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