Prevalence of Normoalbuminuric Chronic Kidney Disease and Its Risk Factors in Patients With Type 2 Diabetes Attending the Diabetes Center of Assiut University Hospital
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Prevalence of Normoalbuminuric chronic kidney disease
研究概览
简要总结
- Assess the prevalence of normoalbuminuric CKD in Type 2 diabetes.
- Study the risk factors of normoalbuminuric CKD in patients with type 2 diabetes.
详细描述
Diabetes mellitus (DM) is considered a major cause of chronic kidney disease (CKD), where about 40% of the diabetics develop diabetic kidney disease (DKD) resulting in albuminuria, reduction of glomerular filtration rate (GFR), or both .
Albuminuria was widely considered the first clinical sign of DKD, therefore, it has been used as a screening test for DKD. However, recent studies showed that a significant number of T2DM patients have a decreased GFR with normoalbuminuria, known as non-albuminuric DKD (NA-DKD) .
The use of albuminuria as an early marker of DKD onset or progression requires a careful interpretation because in diabetics, albuminuria has a great tendency to return to normal spontaneously. Evidence based studies reported that about 18-51 percent of T2DM (followed during 2-10 years) present first with albuminuria turn to normoalbuminurics spontaneously during the period of follow-up .
The United Kingdom Prospective Diabetes Study (UKPDS) reported that some diabetics pass directly from a normoalbuminuria to renal insufficiency (0.1% per year) .
Albuminuria as a marker of glomerular lesion progression has some limitations because of its intra-patient variability and possibility of spontaneous regress (in >50% of the patients with low levels of albuminuria), in contrast with GFR that has low variability and infrequent improvement .
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age >18 -65 years .
- •Diagnosed previously with T2DM.
排除标准
- •Patients with type 1 diabetes,
- •Patients with secondary diabetes,
- •Patients with gestational diabetes
- •Patients with severe acute or chronic hepatic or cardiac diseases.
- •Patients with Past or present history of malignancy .
- •Patients with in need for renal replacement therapy.
- •Patients with other probable causes for CKD.
- •Patients with an active urinary sediment and nephrotic - range proteinuria .
结局指标
主要结局
Prevalence of Normoalbuminuric chronic kidney disease
时间窗: Baseline
The required sample size(200 patients) has been calculated using the EPI info version which achieve power of study 80%.
次要结局
未报告次要终点
研究者
Martina Michael Wadae
clinical investigator
Assiut University
