A cross sectional observational study to determine the prevalence of chronic renal dysfunction amongtype 2 diabetes mellitus patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,400
- 试验地点
- 7
- 主要终点
- Percentage of type-2 diabetic subjects with chronic renal dysfunction
研究概览
简要总结
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" /
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Percentage of type-2 diabetic subjects with chronic renal dysfunction
时间窗: Single time point
次要结局
- 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)