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| ID | Type | Description | Link |
|---|---|---|---|
| NIS-DIN-XXX-2014/1 | Other Identifier | AstraZeneca |
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This non-interventional, multi-centric, cross-sectional study is aimed to determine the prevalence of Chronic Kidney Disease in Indian patients with Type 2 Diabetes (T2DM). 3000 patients will be enrolled from 30 investigative sites all over the country. Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.
This is an observational, multicenter, cross-sectional study to be conducted at 30 sites in India. Endocrinologist/ Diabetologist from multiple private clinics will evaluate the Type 2 Diabetes patients. The study will be conducted over 9-10 months and will be started after obtaining written approval of Independent Ethics Committee (IEC) and written Informed consent of the patient. . Each investigative site will be expected to enrol 100 subjects. All the procedures will be completed in a single day.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T2DM patients with Chronic Kidney Disease | T2DM patients with Chronic Kidney Disease |
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| Measure | Description | Time Frame |
|---|---|---|
| The proportion of T2DM patients with Chronic Kidney Disease (CKD) | The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. GFR below 90 ml/min/1.73 m2 is defined as CKD. we will also classify CKD into various groups as per the KDIGO 2013. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of T2DM patients in various stages of CKD | The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria. We will also classify CKD into various groups as per the KDIGO (KIDNEY DISEASE IMPROVING GLOBAL OUTCOMES) 2013. | 1 day |
| Frequency of T2DM patients with CKD in patients with different duration of T2DM |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 3000 T2DM patients of either gender with age of 18 years and more will be enrolled in the study after the Informed Consent Process.
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Prasanna Kumar K.M, DM | Endocrinology Center for Diabetes and Endocrine Care | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ahmedabad | India | ||||
| Research Site |
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| Label | URL |
|---|---|
| CSR\_Synopsis | View source |
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The proportion of T2DM patients with CKD as per GFR (Glomerular Filtration Rate)criteria.we will also classify CKD into various groups as per the KDIGO 2013. |
| 1 day |
| Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD | Frequency of patients with HbA1C (Glycated Haemoglobin) less than 7% in T2DM patients with and without CKD. we will correlate prevalence of CKD with HbA1C level. | 1 day |
| Bangalore |
| India |
| Research Site | Chandigarh | India |
| Research Site | Chennai | India |
| Research Site | Coimbatore | India |
| Research Site | Delhi | India |
| Research Site | Ghaziabad | India |
| Research Site | Hyderabad | India |
| Research Site | Jaipur | India |
| Research Site | Kanpur | India |
| Research Site | Karnāl | India |
| Research Site | Kolkata | India |
| Research Site | Ludhiana | India |
| Research Site | Mumbai | India |
| Research Site | Noida | India |
| Research Site | Pune | India |
| Research Site | Rohtak | India |
| Research Site | Trivandrum | India |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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