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临床试验/NCT04411342
NCT04411342Unknown不适用

Prevalence of Normoalbuminuric Chronic Kidney Disease and Its Risk Factors in Patients With Type 2 Diabetes Attending the Diabetes Center of Assiut University Hospital

Assiut University0 个研究点目标入组 200 人开始时间: 2020年12月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martina Michael Wadae

clinical investigator

Assiut University

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