An Observational, Cross Sectional Study to Assess the Prevalence of Chronic Kidney Disease in Type 2 Diabetes Patients in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- The proportion of T2DM patients with Chronic Kidney Disease (CKD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known cases of T2DM.
- •Male and female patients aged 18 years and above.
- •Must provide written Informed consent.
排除标准
- •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.
结局指标
主要结局
The proportion of T2DM patients with Chronic Kidney Disease (CKD)
时间窗: 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.
次要结局
- Frequency of T2DM patients in various stages of CKD(1 day)
- Frequency of T2DM patients with CKD in patients with different duration of T2DM(1 day)
- Frequency of patients with HbA1C less than 7% in T2DM patients with and without CKD(1 day)