Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07532863

A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants

The purpose of the study is to investigate the cardiovascular disease (CVD) risk profile among participants newly diagnosed with type 2 diabetes mellitus (T2DM) in Southeast Asia (CRISTAL SEA). It's a retrospective chart-review across five Southeast Asian countries to characterize newly diagnosed T2DM participants and how their CVD risk is distributed, using data from the year before diagnosis and roughly the first year after diagnosis.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Siloam Hospitals Lippo Village, Tangerang, Banten, Indonesia

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged greater than equal to (≥) 40 and less than (<) 70 years
  • Male or female
  • Newly diagnosed with T2DM and initiated on anti-hyperglycemic treatment between 1 January 2022 and 31 December 2023

Exclusion criteria

  • If any exclusion criterion is met, the participant will be excluded from the study.
  • T1DM or gestational diabetes
  • Prescribed with any anti-hyperglycemic medications before first diagnosis of T2DM
  • Pregnant women
  • With pre-existing atherosclerotic CVD including coronary heart disease, stroke, transient ischemic attack, or peripheral artery disease
  • Died within 12 months after first diagnosis of T2DM
  • Lost to follow-up i.e., no visit 12 months (± 3 months) after first diagnosis of T2DM

Treatment and study plan

No treatment given

Other

No treatment given

Primary outcomes

  1. Cardiometabolic profile: Systolic blood pressure at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Millimetres of mercury (mmHg).

  2. Cardiometabolic profile: Waist circumference at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in centimetre (cm).

  3. Cardiometabolic profile: Hip circumference at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in cm.

  4. Cardiometabolic profile: Height at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in cm.

  5. Cardiometabolic profile: Weight at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in kilogram (kg).

  6. Cardiometabolic profile: Total cholesterol at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in millimoles per liter (mmol/L).

  7. Cardiometabolic profile: High-density lipoprotein cholesterol (HDL-C) at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in mmol/L.

  8. Cardiometabolic profile: Low-density lipoprotein cholesterol (LDL-C) at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in mmol/L.

  9. Cardiometabolic profile: Non High-density lipoprotein cholesterol (Non-HDL-C) at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in mmol/L.

  10. Cardiometabolic profile: Triglycerides at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in mmol/L.

  11. Cardiometabolic profile: Glycated haemoglobin (HbA1c) at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in mmol/L.

  12. Cardiometabolic profile: Fasting plasma glucose (FPG) at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in mmol/L.

  13. Cardiometabolic profile: estimated glomerular filtration rate (eGFR) at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in mL/min/1.73m^2.

  14. Cardiometabolic profile: Serum creatinine at baseline

    Time frame: At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date

    Measured in mL/min/1.73m^2.

  15. Proportion of participants classified into CVD risk categories (very high, high, moderate or low risk) - Yes/No

    Time frame: At baseline: Status at the index date or, if unavailable, the closest record within the 12 months prior to the index date

    Measured in percentage (%) of participants.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Retrospective Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus Participants in Southeast Asia

Acronym: CRISTALSEA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.