Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2DM Cohort | Participants with T2DM identified in south asian countries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No treatment given | Other | No treatment given |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiometabolic profile: Systolic blood pressure at baseline | Millimetres of mercury (mmHg). | 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 | Measured in centimetre (cm). | 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 | Measured in cm. | 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 | Measured in cm. | 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 | Measured in kilogram (kg). | 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 | Measured in millimoles per liter (mmol/L). | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Participants with T2DM identified in south asian countries.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Siloam Hospitals Lippo Village | Not yet recruiting | Tangerang | Banten | 15810 | Indonesia | |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measured in mmol/L. |
| 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 | Measured in mmol/L. | 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 | Measured in mmol/L. | 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 | Measured in mmol/L. | At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date |
| Cardiometabolic profile: Glycated haemoglobin (HbA1c) at baseline | Measured in mmol/L. | At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date |
| Cardiometabolic profile: Fasting plasma glucose (FPG) at baseline | Measured in mmol/L. | At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date |
| Cardiometabolic profile: estimated glomerular filtration rate (eGFR) at baseline | Measured in mL/min/1.73m^2. | At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date |
| Cardiometabolic profile: Serum creatinine at baseline | Measured in mL/min/1.73m^2. | At baseline: Measurement at the index date or, if unavailable, the closest measurement within the 12 months prior to the index date |
| Proportion of participants classified into CVD risk categories (very high, high, moderate or low risk) - Yes/No | Measured in percentage (%) of participants. | At baseline: Status at the index date or, if unavailable, the closest record within the 12 months prior to the index date |
| Siloam Hospitals Surabaya |
| Enrolling by invitation |
| Surabaya |
| East Java |
| 60281 |
| Indonesia |
| University Malaya Medical Centre | Enrolling by invitation | Lembah Pantai | Kuala Lumpur | 59100 | Malaysia |
| National Heart Institute | Not yet recruiting | Kuala Lumpur | 50400 | Malaysia |
| The Medical City Ortigas | Not yet recruiting | Pasig | National Capital Region | 1800 | Philippines |
| Novo Nordisk Investigational Site | Recruiting | Singapore | Singapore |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided