An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease in Type 2 Diabetes Patients in India
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- AstraZeneca
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- The proportion of T2DM patients with Chronic Kidney Disease (CKD)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
The proportion of T2DM patients with Chronic Kidney Disease (CKD)
Time Frame: 1 day
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.
Secondary Outcomes
- Frequency of T2DM patients in various stages of CKD(1 day)
- Frequency of T2DM patients with CKD in patients with different duration of T2DM(1 day)
- Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD(1 day)