An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease (CKD) in Type 2 Diabetes Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease in Type 2 Diabetes Patients in India

Conditions
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Diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known cases of T2DM. Male and female patients aged 18 years and above. Must provide written Informed consent. Exclusion Criteria: Patients with known type-1 diabetes. Patients with any form of acute kidney injury based on investigator's discretion. Patients on maintenance dialysis or known renal transplant patients. Patients who have participated in any interventional study within past 3 months prior to entry in this study. Pregnant women. Patients with symptomatic Urinary Tract Infection (UTI) or with history of hematuria.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2DM patients with Chronic Kidney Disease<br>T2DM patients with Chronic Kidney Disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes