NCT07833007

Brief Summary

metabolic syndrome may be prevalent in familial Mediterrean fever. Dietary limitations are main treatment in metabilc syndrome

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Aug 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Aug 2026Dec 2026

Study Start

First participant enrolled

August 10, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 16, 2026

Last Update Submit

September 16, 2026

Conditions

Familial Mediterranean Fever (FMF )Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • fasting blood glcuose

    it will be assessed in plasma

    it will be assessed after 12 weeks

Secondary Outcomes (7)

  • body mass index

    it will be assessed after 12 weeks

  • waist circumference

    it will be assessed after 12 weeks

  • high density lipoprotein

    it will be assessed after 12 weeks

  • triglycerides

    it will be assessed after 12 weeks

  • systolic blood pressure

    it will be assessed after 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

group I

EXPERIMENTAL

twenty metabolic syndrome participants (adolescents) with familial Mediterrean fever will received low calorie diet for 3 months

Behavioral: low calorie diet

group II

NO INTERVENTION

Twenty metabolic syndrome participants (adolescents) with familial Mediterrean fever will no change their dietary habits for 12 weeks

Interventions

low calorie dietBEHAVIORAL

metabolic syndrome participants (adolescents) with familial Mediterrean fever will received low calorie diet for 3 months

group I

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • metabolic syndrome
  • familial mediterreanean fever

You may not qualify if:

  • cardiac diseases
  • repsiratory diseases
  • tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Familial Mediterranean FeverMetabolic Syndrome

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ali MA Ismail, PHD

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, PhD

CONTACT

+201005154209ali.mohamed@pt.cu.edu.eg

Ali mohamed, PhD

CONTACT

+201033321109ali.mohamed@pt.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of department of physical therapy for cardiovascular respiratory disorder and geriatrics

Study Record Dates

First Submitted

September 16, 2026

First Posted

September 22, 2026

Study Start

August 10, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

September 22, 2026

Record last verified: 2026-09

Locations

EG(1)