Familial Mediterranean Fever (FMF )NCT07833007
Metabolic Syndrome Resposne to Dietary Limitations in Familial Mediterranean Fever in Adolescents
A study testing low calorie diet in people with Familial Mediterranean Fever (FMF ) and Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
metabolic syndrome may be prevalent in familial Mediterrean fever. Dietary limitations are main treatment in metabilc syndrome Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Familial Mediterranean Fever (FMF ), Metabolic Syndrome
- What is being tested?
- low calorie diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- metabolic syndrome
- familial mediterreanean fever
Who cannot join
- cardiac diseases
- repsiratory diseases
- tumors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Giza, Dokki
ali ismail, lecturer, 02 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
metabolic syndrome may be prevalent in familial Mediterrean fever. Dietary limitations are main treatment in metabilc syndrome
Read the detailed description
forty metabolic syndrome participants (adolescents) with familial Mediterrean fever divided equally in to study group received low calorie diet for 3 months and control group who will no change their dietary habits
- Being tested
- low calorie diet
- Medical subject headings
- Familial Mediterranean Fever, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low calorie dietBehavioural
metabolic syndrome participants (adolescents) with familial Mediterrean fever will received low calorie diet for 3 months
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | twenty metabolic syndrome participants (adolescents) with familial Mediterrean fever will received low calorie diet for 3 months Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glcuose
it will be assessed in plasma
Measured: it will be assessed after 12 weeks
Secondary outcomes (7)
body mass index
it will be assessed while patients were on empty stomach and bladder
Measured: it will be assessed after 12 weeks
waist circumference
it will be assessed via tape measurement
Measured: it will be assessed after 12 weeks
high density lipoprotein
it will be assessed in plasma
Measured: it will be assessed after 12 weeks
triglycerides
it will be assessed in plasma
Measured: it will be assessed after 12 weeks
systolic blood pressure
it will be assessed from brachial artery
Measured: it will be assessed after 12 weeks
diastolic blood pressure
it will be assessed from brachial artery
Measured: it will be assessed after 12 weeks
C reactive protein
it will be assessed in plasma
Measured: it will be assessed after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start10 Aug 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean Fever (FMF )Studies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, PHD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833007
- Sponsor's protocol ID
- IRB000-14233-102
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome Resposne to Dietary Limitations in Familial Mediterranean Fever in Adolescents
- ClinicalTrials.gov ID
- NCT07833007
- Acronym / sponsor ID
- IRB000-14233-102
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
metabolic syndrome may be prevalent in familial Mediterrean fever. Dietary limitations are main treatment in metabilc syndrome
Detailed description
forty metabolic syndrome participants (adolescents) with familial Mediterrean fever divided equally in to study group received low calorie diet for 3 months and control group who will no change their dietary habits
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Behavioral: low calorie diettwenty metabolic syndrome participants (adolescents) with familial Mediterrean fever will received low calorie diet for 3 months |
| group II | No intervention | –Twenty metabolic syndrome participants (adolescents) with familial Mediterrean fever will no change their dietary habits for 12 weeks |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- metabolic syndrome
- familial mediterreanean fever
Key exclusion criteria (3 listed)
- cardiac diseases
- repsiratory diseases
- tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low calorie dietmetabolic syndrome participants (adolescents) with familial Mediterrean fever will received low calorie diet for 3 months | Behavioural | group I |
Primary outcome
fasting blood glcuose
Time frame: it will be assessed after 12 weeks
it will be assessed in plasma
7 secondary outcomes
body mass index
Time frame: it will be assessed after 12 weeks
waist circumference
Time frame: it will be assessed after 12 weeks
high density lipoprotein
Time frame: it will be assessed after 12 weeks
triglycerides
Time frame: it will be assessed after 12 weeks
systolic blood pressure
Time frame: it will be assessed after 12 weeks
diastolic blood pressure
Time frame: it will be assessed after 12 weeks
C reactive protein
Time frame: it will be assessed after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Related trials for Familial Mediterranean Fever (FMF )
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
Familial Mediterranean Fever (FMF), Autoinflammation
RecruitingPhase 3
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Behçet's Disease, Juvenile Psoriatic Arthritis
Not yet recruitingPhase 3
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
Familial Mediterranean Fever, FMF
Not yet recruitingObservational study
Genotype and Phenotype in Pediatric Familial Mediterranean Fever
Familial Mediterranean Fever
Not yet recruitingObservational study
Serum EBI-3 Protein Levels in Behçet's Disease
Behçet Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali MA Ismail, PHD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low calorie diet in people with Familial Mediterranean Fever (FMF ) and Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, PhD (+201005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting blood glcuose (time frame: it will be assessed after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.