Prevalence of chronic kidney disease among Indian subjects with type-2 diabetes

Completed

• Conditions: Chronic kidney disease, unspecified, Type 2 diabetes ,

• Registration Number: CTRI/2012/07/002763
• Lead Sponsor: Shri Sitaram Shiksha evam Paryavaran Samaj Kalyan Samiti Reg

Brief Summary

The current cross sectional observational study has been designed to determine the prevalence of chronic renal dysfunction among type-2 diabetics. In this study 1400 type -2 diabetic subjects will be enrolled at 7 centers across the country (India) to meet scientific objectives. The primary outcome of the study is percentage of type-2 diabetic subjects with chronic renal dysfunction and secondary objectives are: 1. Percentage of subjects among different stages of chronic renal dysfunction. 2. Ratio of chronic renal dysfunction subjects in various age group, gender and BMI(≤30kg/m2 and >30 kg/m2). 3. Ratio of co-morbid conditions in different stages of chronic renal dysfunction. The study will be terminated once the target enrollment is achieved. A maximum of 250 subjects will be enrolled at each participating sites over a period of 60 working days. First 10 subjects in a day who meet the eligibility criteria will be enrolled to participate into the study at each site.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-14
• Last Update Posted: 2020-05-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

1.Subject with age ≥ 18 years 2.Subjects who give written informed consent to participate in the study 3.Subjects of either sex with confirmed diagnosis of type-2 diabetes.

Exclusion Criteria

• 1.Subjects with type-1 diabetes (Insulin dependent diabetes mellitus).
• 2.Subjects with any form of acute kidney injury based on investigator discretion.
• 3.Subjects who are pregnant or have positive urine pregnancy test (UPT) 4.Subjects with history of alcohol or drug abuse.
• 5.Female subjects who are actively menstruating 6.Subjects who have participated in any other study within past 3 months prior to entry in this study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of type-2 diabetic subjects with chronic renal dysfunction	Single time point

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects among different stages of chronic renal dysfunction
Ratio of chronic renal dysfunction subjects in various age group, gender and BMI(≤30kg/m2 and 30 kg/m2)
Ratio of co-morbid conditions in different stages of chronic renal dysfunction	Single time point

Trial Locations

Locations (7)

Bharti Hospital; 🇮🇳 Karnal, HARYANA, India

Department of Endocrinology; 🇮🇳 Bangalore, KARNATAKA, India

Department of Endocrinology,; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Department of Endocrinology, KEM Hospital,; 🇮🇳 Mumbai, MAHARASHTRA, India

Diabetes, Obesity & Thyroid Center,; 🇮🇳 Gwalior, MADHYA PRADESH, India

Excel Care Hospitals; 🇮🇳 Bongaigaon, ASSAM, India

Private clinic; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Bharti Hospital

🇮🇳Karnal, HARYANA, India

Dr Sanjay Kalra

Principal investigator

9896048555

bridenknl@gmail.com