ClinicalTrials.gov record NCT07833007
Metabolic Syndrome Resposne to Dietary Limitations in Familial Mediterranean Fever in Adolescents
Metabolic Syndrome Resposne to Dietary Limitations in Familial Mediterranean Fever in Adolescents
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This randomized study compares a low-calorie diet for 3 months with no dietary change in adolescents who have familial Mediterranean fever (FMF) and metabolic syndrome. Forty participants are planned, split into two equal groups. The main measurement is fasting blood glucose after 12 weeks; other metabolic measures are also assessed.
What it is studying. The study tests whether following a low-calorie diet for 12 weeks produces changes in fasting blood glucose and other metabolic markers in adolescents with FMF and metabolic syndrome.
What the researchers hope to learn. Scientific goals are to learn whether dietary calorie restriction affects fasting glucose and other metabolic markers in adolescents who have FMF and metabolic syndrome, and to provide data about diet as a treatment approach in this population.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
metabolic syndrome may be prevalent in familial Mediterrean fever. Dietary limitations are main treatment in metabilc syndrome
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Behavioral
- low calorie diet
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- metabolic syndrome
- familial mediterreanean fever
Exclusion criteria
- cardiac diseases
- repsiratory diseases
- tumors
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are randomly assigned to follow a low-calorie diet for 12 weeks or to keep their usual diet. After 12 weeks the study assesses plasma tests for fasting blood glucose, high-density lipoprotein, triglycerides, and C‑reactive protein. The study also measures body mass index (while participants are fasting and with an empty bladder), waist circumference (tape measurement), and systolic and diastolic blood pressure (from the brachial artery). The registry record does not describe other visits, procedures, or participant support services.
How the study is structured. An interventional, randomized, parallel-group study with single masking. About 40 adolescents are assigned at random to either a low-calorie diet for 3 months (experimental group) or to continue their usual diet (control group). Key measurements — including fasting blood glucose, body mass index, waist circumference, lipid levels, blood pressure, and C‑reactive protein — are assessed after 12 weeks.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in Egypt. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on familial Mediterranean fever
Important dates
- Study start
- Aug 10, 2026
- Primary completion
- Dec 15, 2026 (estimated)
- Study completion
- Dec 15, 2026 (estimated)
- Target enrollment
- 40 participants (estimated)
- Last updated on registry
- Sep 22, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Cairo University
- Principal investigator
- Ali Mohamed Ali ismail, lecturer of department of physical therapy for cardiovascular respiratory disorder and geriatrics
Cairo University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Ali Ismail, PhD 📞 +201005154209 ✉ ali.mohamed@pt.cu.edu.eg
- Ali mohamed, PhD 📞 +201033321109 ✉ ali.mohamed@pt.cu.edu.eg
Participating sites (1)
- Cairo UniversityRecruiting
Giza, Dokki · Egypt
- ali ismail, lecturer · 02 01005154209 · ali.mohamed@pt.cu.edu.eg
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- study group
- One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
- control group
- The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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