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临床试验/NCT07130318
NCT07130318招募中不适用

Mediterranean Diet in Familial Mediterranean Fever: Is Fatty Liver Affected by Addition of Elliptical Aerobic Exercise

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年5月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
aspartate transaminase

研究概览

简要总结

Familial Mediterranean fever (FMF) affect liver and causes some dysfunctions including non-alcoholic fatty liver.. still exercise and diet limitation is the treatment for this case

详细描述

Familial Mediterranean fever (FMF women with fatty liver) will be collected to be cateogarized to group I or group II. Every group OF FMF will contain 20 FMF women. Both groups will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months. Group I will also perform elliptical aerobic exercise (this exercise will be applied for 40 minutes three times weekly and this exercise will be maintained for 6 months)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •familial Mediterrean fever women
  • •obese women
  • •women who have fatty live (non alcoholic type)

排除标准

  • •cardiac patients
  • •respiratory disease
  • •renal disease

研究组 & 干预措施

group number 1

Experimental

Familial Mediterranean fever (FMF women ) will be collected in this group. the group OF FMF will contain 20 FMF women. the group will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months. also, this group, Group I, will also perform elliptical aerobic exercise (this exercise will be applied for 40 minutes three times weekly and this exercise will be maintained for 6 months)

干预措施: exercise plus diet restriction (Behavioral)

group number 2

Active Comparator

Familial Mediterranean fever (FMF women ) will be collected in this group. the group OF FMF will contain 20 FMF women. the group will follow their colchicine (traditional daily drug therapy for FMF) in addition to Mediterranean diet for six months.

干预措施: diet restriction (Behavioral)

结局指标

主要结局

aspartate transaminase

时间窗: it will be measured after 6 months

it is a hepatic enzyme

次要结局

  • erythrocyte sedimentation rate(it will be measured after 6 months)
  • alanine transaminase(it will be measured after 6 months)
  • body mass index(it will be measured after 6 months)
  • waist circumference(it will be measured after 6 months)
  • high density lipoprotein(it will be measured after 6 months)
  • triglycerides(it will be measured after 6 months)
  • cholesterol(it will be measured after 6 months)
  • low density lipoprotein(it will be measured after 6 months)
  • c reactive protein(it will be measured after 6 months)

研究者

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

Ali Mohamed Ali ismail

lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Cairo University

研究点 (1)

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