NCT07130318

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2026

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

8 months

First QC Date

August 12, 2025

Last Update Submit

August 18, 2025

Conditions

Familial Mediterranean FeverNon-Alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • aspartate transaminase

    it is a hepatic enzyme

    it will be measured after 6 months

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

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)

Behavioral: exercise plus diet restriction

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.

Behavioral: diet restriction

Interventions

exercise plus diet restrictionBEHAVIORAL

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)

group number 1
diet restrictionBEHAVIORAL

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.

group number 2

Eligibility Criteria

Age30 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • cardiac patients
  • respiratory disease
  • renal disease
  • cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Familial Mediterranean FeverNon-alcoholic Fatty Liver Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesFatty LiverLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ali MA Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Ismail, lecturer

CONTACT

01005154209ali.mohamed@pt.cu.edu.eg

Ali Ismail, lecturer

CONTACT

allooka2012@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Cardiovascular, Respiratory disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 19, 2025

Study Start

May 8, 2025

Primary Completion

January 8, 2026

Study Completion

January 8, 2026

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations

EG(1)