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

Completed

• Conditions: Diabetes

• Registration Number: NCT02208921
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-04
• Study First Posted: 2014-08-05
• Study Start: 2014-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. Known cases of T2DM.
2. Male and female patients aged 18 years and above.
3. Must provide written Informed consent.

Exclusion Criteria

1. Patients with known type-1 diabetes.
2. Patients with any form of acute kidney injury based on investigator's discretion.
3. Patients on maintenance dialysis or known renal transplant patients.
4. Patients who have participated in any interventional study within past 3 months prior to entry in this study.
5. Pregnant women.
6. Patients with symptomatic Urinary Tract Infection (UTI) or with history of hematuria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of T2DM patients with Chronic Kidney Disease (CKD)	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 Outcome Measures

Name	Time	Method
Frequency of T2DM patients in various stages of CKD	1 day	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.
Frequency of T2DM patients with CKD in patients with different duration of T2DM	1 day	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.
Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD	1 day	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.

Trial Locations

Locations (1)

Research Site; 🇮🇳 Trivandrum, India