Diabetes Mellitus, Type 2
Conditions
Brief summary
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
OTHERNo treatment given
No treatment given
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiometabolic profile: Systolic blood pressure at baseline | 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). |
| Cardiometabolic profile: Waist circumference at baseline | 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). |
| Cardiometabolic profile: Hip circumference at baseline | 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. |
| Cardiometabolic profile: Height at baseline | 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. |
| Cardiometabolic profile: Weight at baseline | 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). |
| Cardiometabolic profile: Total cholesterol at baseline | 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). |
| Cardiometabolic profile: High-density lipoprotein cholesterol (HDL-C) at baseline | 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. |
| Cardiometabolic profile: Low-density lipoprotein cholesterol (LDL-C) at baseline | 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. |
| Cardiometabolic profile: Non High-density lipoprotein cholesterol (Non-HDL-C) at baseline | 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. |
| Cardiometabolic profile: Triglycerides at baseline | 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. |
| Cardiometabolic profile: Glycated haemoglobin (HbA1c) at baseline | 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. |
| Cardiometabolic profile: Fasting plasma glucose (FPG) at baseline | 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. |
| Cardiometabolic profile: estimated glomerular filtration rate (eGFR) at baseline | 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. |
| Cardiometabolic profile: Serum creatinine at baseline | 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. |
| Proportion of participants classified into CVD risk categories (very high, high, moderate or low risk) - Yes/No | 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. |
Countries
Indonesia, Malaysia, Philippines, Singapore
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed