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

Diabetes Clinical Trial

— START-INDIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208921
• Other study ID #: D1843R00050
• Secondary ID: NIS-DIN-XXX-2014
• Status: Completed
• Phase: N/A
• First received: August 4, 2014
• Last updated: March 24, 2016
• Start date: September 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
India	Research Site	Ahmedabad
India	Research Site	Bangalore
India	Research Site	Chandigarh
India	Research Site	Chennai
India	Research Site	Coimbatore
India	Research Site	Delhi
India	Research Site	Ghaziabad
India	Research Site	Hyderabad
India	Research Site	Jaipur
India	Research Site	Kanpur
India	Research Site	Karnal
India	Research Site	Kolkata
India	Research Site	Ludhiana
India	Research Site	Mumbai
India	Research Site	Noida
India	Research Site	Pune
India	Research Site	Rohtak
India	Research Site	Trivandrum

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   CSR_Synopsis