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临床试验/NCT04323007
NCT04323007Unknown不适用

Thyroid Dysfunction in Patients With Nephrotic Syndrome

Merna Makram0 个研究点目标入组 100 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
主要终点
Hypothyroidism in patients with nephrotic syndrome

研究概览

简要总结

This study is to evaluate Thyroid Hormone profile in patients with Nephrotic syndrome to identify clinical predictor of Thyroid dysfunction in patients with Nephrotic syndrome

详细描述

Nephrotic syndrome (NS) is one of the most popular glomerular diseases all over the world It result in loss of various macromolecules which exist in the plasma and bound to plasma proteins. They are carried away and lost in the urine due to increase glomerular membrane permeability.The abnormalities arising as a result of persistence of generalized edema , substantial heavy proteinuria >3,5 gm/24 h 3, hypoalbuminemia<30 g/L and hyperlipidemia Also, nephrotic syndrome may associated with thromboembolism and increase risk of infection, vitamin D deficiency, Iron deficiency and endocrine abnormalities such as primary Hypothyroidism.The interaction between kidney and Thyroid hormone is an important factor in the normal functioning of both the vital organs, thyroid hormone play a major role in early development of kidney structurally and regulation of major glomerular and tubular function and water and electrolytes balance .Kidneys on other hand are important in the metabolism and elimination of Thyroid Hormone.The effect of nephrotic syndrome on thyroid function can be explained by presence of proteinuria and loss of Thyroid binding globulins (TBG) in urine

which lead to decrease in Total T3,Total T4,free T3 and free T4 and consequently increase in TSH from the pituitary gland with over function of thyroid gland in order to maintain Thyroid hormone levels. Another theory explain association between nephrotic syndrome and thyroid dysfunction is Autoimmunity which can attack both organs and may also cause abnormal function of both organs. Thus, subclinical Hypothyroidism and overt Hypothyroidism may happen in NS patients and CKD patients

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Nephrotic syndrome defined by the following:
  • •Generalized edema
  • •Urine protein excretion > 3,5 g/24 hours
  • •Urine protein to creatinine ratio > 3,500mg/g
  • •Serum albumin level less than 30 g/L

排除标准

  • •Patients < 18 years old 2) Patients who have Thyroid diseases, current or past history of thyroid hormone or antithyroid drug intake.
  • •Patients who have diabetes mellitus or autoimmune diseases as systemic lupus erythematosus and RA 4) Medications known to affect thyroid function. 5) Patients with liver cirrhosis and chronic liver disease as augmentin

研究组 & 干预措施

Nephrotic syndrome patients

Other

This study is to evaluate Thyroid Hormone profile in patients with Nephrotic syndrome to identify clinical predictor of Thyroid dysfunction in patients with Nephrotic syndrome

干预措施: Nephrotic patients (Diagnostic Test)

结局指标

主要结局

Hypothyroidism in patients with nephrotic syndrome

时间窗: 1year

Decrease T3 and/or T4 and/or increase TSH in patients with proteinurea more than 3.5 mg

次要结局

未报告次要终点

研究者

发起方
Merna Makram
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Merna Makram

Thyroid Dysfunction in patients with nephrotic syndrome

Assiut University

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