A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants
Recruiting · NCT07532863 · Observational (researchers observe without assigning treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
No treatment given
What this trial is about
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.
Who can take part
Age range
40 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
6 locations listed.
- National Heart Institute - Kuala Lumpur, Malaysia
- Novo Nordisk Investigational Site - Singapore, Singapore
- Siloam Hospitals Lippo Village - Tangerang, Banten, Indonesia
- Siloam Hospitals Surabaya - Surabaya, East Java, Indonesia
- University Malaya Medical Centre - Lembah Pantai, Kuala Lumpur, Malaysia
- The Medical City Ortigas - Pasig, National Capital Region, Philippines