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Recruiting NCT07532863

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

— Observational Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No treatment given.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia, Malaysia, Philippines, Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other No treatment given
    No treatment given

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Indonesia · 2 centers
  • Siloam Hospitals Lippo Village — Tangerang
  • Siloam Hospitals Surabaya — Surabaya
Malaysia · 2 centers
  • University Malaya Medical Centre — Lembah Pantai
  • National Heart Institute — Kuala Lumpur
Philippines · 1 center
  • The Medical City Ortigas — Pasig
Singapore · 1 center
  • Novo Nordisk Investigational Site — Singapore

Identifiers

NCT: NCT07532863 · DAS-8606

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗