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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Ahmedabad, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: START-INDIA

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Aug 5, 2014
Registry last updated: Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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