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临床试验/NCT06327009
NCT06327009已完成不适用

Effect of Ramadan Fasting on Kidney Function and Proteinuria in Patients With Glomerulonephritis: a Prospective Observational Clinical Trial

Alexandria University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in kidney function

研究概览

简要总结

This research aims to assess effects of ramadan fasting on kidney function and proteinuria in patients with glomerulonephritis.

详细描述

Fasting from sunrise to sunset during the Islamic holy month of Ramadan is one of the five pillars of the Islamic faith. Duration of the fasting ranges from 10 to 18 hours per day according to the geographic location and the season. Although people with chronic illnesses are exempted from fasting according to Islamic beliefs, many patients insist on fasting against medical advice. Through the last three decades many reports studied the potential risks and benefits of fasting Ramadan in regular hemodialysis (HD) patients. Target points of investigation were different. Most of them were focusing on the electrolytes and nutritional changes. Fewer reports tested the mortality rate. In a multicenter observational study, 2055 Egyptian patients from 25 HD units were studied for frequency of fasting in Ramadan and the possible effect of fasting on clinical and biochemical variables. The investigators concluded that nearly 47% of the study patients fasted at least few days of Ramadan. They recommended that HD patients should be encouraged to discuss the option of fasting in Ramadan with their HD staff who might be able to give advice on whether to allow them to fast in days off dialysis with special precautions regarding associated comorbidities, especially diabetes and coronary artery disease. Most of the studies focused on the effects of fasting the month of Ramadan in CKD and hemodialysis patients, but no research assessed these effects specifically in patients with glomerulonephritis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with biopsy proven glomerulonephritis with eGFR ≥ 30 ml/min for more than 3 months (exception is nephrotic patients with positive anti-PLA2R indicative of primary membranous).

排除标准

  • Patients with medical contraindications for fasting.
  • Patients with eGFR < 30 ml/min.
  • Patients with acute cardiovascular disease.
  • uncontrolled diabetes mellitus.
  • active or chronic inflammatory disease.
  • Acute liver disease.
  • Pregnancy.

结局指标

主要结局

Change in kidney function

时间窗: 4 weeks (month of ramadan)

By assessing change in eGFR

Change in proteinuria

时间窗: 4 weeks (month of ramadan)

By assessing change in protein to creatinine ratio in urine

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

Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD

assistant professor

Alexandria University

研究点 (1)

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