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

Overview

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.

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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 2015

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.

Arms, Groups and Cohorts

  • T2DM patients with Chronic Kidney Disease
    • T2DM patients with Chronic Kidney Disease

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Frequency of T2DM patients in various stages of CKD
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Prasanna Kumar K.M, DM, Study Chair, Endocrinology Center for Diabetes and Endocrine Care

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.