Clinical trial NCT02208921: An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease (CKD) in Type 2 Diabetes Patients
Official title: An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease in Type 2 Diabetes Patients in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Type 2 Diabetes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 3000 T2DM patients of either gender with age of 18 years and more will be enrolled in the study after the Informed Consent Process.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of T2DM patients with Chronic Kidney Disease (CKD)
timeFrame: 1 day
Secondary outcomes:
measure: Frequency of T2DM patients in various stages of CKD
timeFrame: 1 day
measure: Frequency of T2DM patients with CKD in patients with different duration of T2DM
timeFrame: 1 day
measure: Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD
timeFrame: 1 day
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Chandigarh
country: India
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Coimbatore
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Ghaziabad
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Kanpur
country: India
facility: Research Site
city: Karnal
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Ludhiana
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: Noida
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Rohtak
country: India
facility: Research Site
city: Trivandrum
country: India
facility: Research Site
Study officials:
affiliation: Endocrinology Center for Diabetes and Endocrine Care
name: Dr. Prasanna Kumar K.M, DM
role: STUDY_CHAIR
References: