Metabolic Disorders in ChildrenNCT05681104
Early Detection of Metabolic Syndrome and Obesity Comorbidities
An observational study of Metabolic Disorders in Children, run by Assiut University.
Trial summary
To assess : Compare predictive value of waist to-height ratio and bio-electrical impedance analysis versus BMI in early detection of metabolic syndrome parameters and complication of obesity. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Metabolic Disorders in Children
- What is being tested?
- Waist-height ratio, body mass index and Bio-electrical impedance analysis
- How many people
- 275 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Obese children (Body mass index >95th percentile) aged 6-12 years old
Who may be able to join
- Obese children (Body mass index >95th percentile) aged 6-12 years old
Who cannot join
- Patient who aged <6 or>12 years Presence of chronic illness (diabetes, asthma, endocrine disease) Presence of obesity as a part of genetic syndrome Presence of history of long term drug intake (corticosteroids )
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Bio-electrical Impedance Analysis and Waist-height Ratio Versus Body Mass Index in Early Detection of Metabolic Syndrome and Obesity Comorbidities in Primary School Aged Obese Children
To assess :
Compare predictive value of waist to-height ratio and bio-electrical impedance analysis versus BMI in early detection of metabolic syndrome parameters and complication of obesity.
Read the detailed description
Childhood Obesity is defined as a body mass index (BMI) above the 95th percentile for sex and age.It is Labelled as a national epidemic and affects one in three adults and one in six children in the United States of America.Worldwide several countries have witnessed a double or triple escalation in the prevalence of obesity in the last three decades probably due to urbanization, sedentary lifestyle, and increase consumption of high-Calorie processed food.Based upon the World Population Review 2020, Egypt ranked as the highest 19th country in the world and the 7th highest country in the Arab region, with a 32% obesity rate. In Qena government study was conducted on 1000 students were chosen randomly from all grades of primary schools the overall prevalence of obesity and Overweight was 13.9% and 16.2% respectively. Girls were more obese than boys.
The alarming increase in childhood obesity foreshows a tremendous burden of chronic disease prevention in the future public healthcare systems worldwide. Obesity prevention is a critical factor in controlling Obesity-related Non-communicable diseases (OR-NCDs), including insulin resistance/ metabolic syndrome, coronary artery Disease ,cancer and psychological problems.
Metabolic syndrome is a clustering of abdominal obesity-associated factors including elevated waist Circumference(WC), elevated blood pressure (BP), elevated glucose, elevated triglycerides (TGs) or reduced high-Density lipoprotein cholesterol (HDL-C).two key components of metabolic syndrome glucose and triglycerides are overproduced by the fatty liver. So liver is therefore a key determinant of metabolic abnormalities and prevalence of both metabolic syndrome and Non-alcoholic fatty liver (NAFLD) increases with obesity.
There are various diagnostic methods for metabolic syndrome in children and adolescents. Based on the world Health organization(WHO) criteria it diagnosed when three or more of the following features are found: body Mass index (BMI):>95th percentile, hyperinsulinemia or impaired fasting glucose or impaired glucose tolerance, BP>95th percentile, triglycerides (TG)>105/136 mg/dL (1.2/1.5 mmol/L) for children aged<10 and>10 years Respectively ,high density lipoprotein (HDL)-C<35 mg/dL (0.9 mmol/L).
While BMI is a simple measure calculated by dividing the body weight by the squared height, it does not fully Reflect adiposity or body composition. So a better anthropometric measures than BMI to screen for central obesity are needed. . Among the anthropometric measures used to evaluate adiposity, the waist circumference and waist-To-height ratio (WHtR) can be easily measured in clinical settings and can act as an indicator of central obesity and cardio metabolic risk.
In this study we will Compare predictive value of waist to-height ratio and bio-electrical impedance analysis versus BMI in early detection of metabolic syndrome.
- Conditions
- Metabolic Disorders in Children
- Being tested
- Waist-height ratio, body mass index, Bio-electrical impedance analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waist-height ratioDiagnostic test
Waist-height ratio as early predictors of metabolic syndrome in primary school obese children
body mass indexDiagnostic test
Body mass index as early predictors of metabolic syndrome in primary school obese children
Bio-electrical impedance analysisDiagnostic test
Bio-electrical impedance analysis as early predictors of metabolic syndrome in primary school obese children
What is being measured
The primary outcome is the main question the study is designed to answer.
screening tool for metabolic syndrome
Bio-electrical impedance analysis as an early predictors of metabolic syndrome in primary school obese children
Measured: At recruitment
Secondary outcomes (1)
metabolic syndrome diagnostic tool
Body mass index as an early predictors of metabolic syndrome in primary school obese children
Measured: At recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study startMar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Metabolic Disorders in ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Shawky Ibrahim Abd Elalem, Assiut University
- Investigators
- Ghada om El-sedaffy, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681104
- Sponsor's protocol ID
- metabolic syndrome in children
- Status last verified
- Oct 2023
- First submitted
- 29 Dec 2022
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rundle AG, Factor-Litvak P, Suglia SF, Susser ES, Kezios KL, Lovasi GS, Cirillo PM, Cohn BA, Link BG. Tracking of Obesity in Childhood into Adulthood: Effects on Body Mass Index and Fat Mass Index at Age 50. Child Obes. 2020 Apr;16(3):226-233. doi: 10.1089/chi.2019.0185.
PubMed 32191541Balasundaram P, Daley SF. Public Health Considerations Regarding Obesity. 2025 Feb 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572122/
PubMed 34283488Henry FJ. Obesity prevention: the key to non-communicable disease control. West Indian Med J. 2011 Jul;60(4):446-51.
PubMed 22097676Liang X, Zhang P, Luo S, Zhang G, Tang X, Liu L. The association of quality of life and personality characteristics with adolescent metabolic syndrome: a cohort study. Health Qual Life Outcomes. 2021 Jun 8;19(1):160. doi: 10.1186/s12955-021-01797-7.
PubMed 34103067
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-electrical Impedance Analysis and Waist-height Ratio Versus Body Mass Index in Early Detection of Metabolic Syndrome and Obesity Comorbidities in Primary School Aged Obese Children
- ClinicalTrials.gov ID
- NCT05681104
- Acronym / sponsor ID
- metabolic syndrome in children
- Conditions
- Metabolic Disorders in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Jan 2023 (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.
To assess :
Compare predictive value of waist to-height ratio and bio-electrical impedance analysis versus BMI in early detection of metabolic syndrome parameters and complication of obesity.
Detailed description
Childhood Obesity is defined as a body mass index (BMI) above the 95th percentile for sex and age.It is Labelled as a national epidemic and affects one in three adults and one in six children in the United States of America.Worldwide several countries have witnessed a double or triple escalation in the prevalence of obesity in the last three decades probably due to urbanization, sedentary lifestyle, and increase consumption of high-Calorie processed food.Based upon the World Population Review 2020, Egypt ranked as the highest 19th country in the world and the 7th highest country in the Arab region, with a 32% obesity rate. In Qena government study was conducted on 1000 students were chosen randomly from all grades of primary schools the overall prevalence of obesity and Overweight was 13.9% and 16.2% respectively. Girls were more obese than boys.
The alarming increase in childhood obesity foreshows a tremendous burden of chronic disease prevention in the future public healthcare systems worldwide. Obesity prevention is a critical factor in controlling Obesity-related Non-communicable diseases (OR-NCDs), including insulin resistance/ metabolic syndrome, coronary artery Disease ,cancer and psychological problems.
Metabolic syndrome is a clustering of abdominal obesity-associated factors including elevated waist Circumference(WC), elevated blood pressure (BP), elevated glucose, elevated triglycerides (TGs) or reduced high-Density lipoprotein cholesterol (HDL-C).two key components of metabolic syndrome glucose and triglycerides are overproduced by the fatty liver. So liver is therefore a key determinant of metabolic abnormalities and prevalence of both metabolic syndrome and Non-alcoholic fatty liver (NAFLD) increases with obesity.
There are various diagnostic methods for metabolic syndrome in children and adolescents. Based on the world Health organization(WHO) criteria it diagnosed when three or more of the following features are found: body Mass index (BMI):>95th percentile, hyperinsulinemia or impaired fasting glucose or impaired glucose tolerance, BP>95th percentile, triglycerides (TG)>105/136 mg/dL (1.2/1.5 mmol/L) for children aged<10 and>10 years Respectively ,high density lipoprotein (HDL)-C<35 mg/dL (0.9 mmol/L).
While BMI is a simple measure calculated by dividing the body weight by the squared height, it does not fully Reflect adiposity or body composition. So a better anthropometric measures than BMI to screen for central obesity are needed. . Among the anthropometric measures used to evaluate adiposity, the waist circumference and waist-To-height ratio (WHtR) can be easily measured in clinical settings and can act as an indicator of central obesity and cardio metabolic risk.
In this study we will Compare predictive value of waist to-height ratio and bio-electrical impedance analysis versus BMI in early detection of metabolic syndrome.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Obese children (Body mass index >95th percentile) aged 6-12 years old
Key inclusion criteria (1 listed)
- Obese children (Body mass index >95th percentile) aged 6-12 years old
Key exclusion criteria (1 listed)
- Patient who aged <6 or>12 years Presence of chronic illness (diabetes, asthma, endocrine disease) Presence of obesity as a part of genetic syndrome Presence of history of long term drug intake (corticosteroids )
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 |
|---|---|---|
| Waist-height ratioWaist-height ratio as early predictors of metabolic syndrome in primary school obese children | Diagnostic test | – |
| body mass indexBody mass index as early predictors of metabolic syndrome in primary school obese children | Diagnostic test | – |
| Bio-electrical impedance analysisBio-electrical impedance analysis as early predictors of metabolic syndrome in primary school obese children | Diagnostic test | – |
Primary outcome
screening tool for metabolic syndrome
Time frame: At recruitment
Bio-electrical impedance analysis as an early predictors of metabolic syndrome in primary school obese children
1 secondary outcome
metabolic syndrome diagnostic tool
Time frame: At recruitment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 32191541Rundle AG, Factor-Litvak P, Suglia SF, Susser ES, Kezios KL, Lovasi GS, Cirillo PM, Cohn BA, Link BG. Tracking of Obesity in Childhood into Adulthood: Effects on Body Mass Index and Fat Mass Index at Age 50. Child Obes. 2020 Apr;16(3):226-233. doi: 10.1089/chi.2019.0185.
- Background: PubMed 34283488Balasundaram P, Daley SF. Public Health Considerations Regarding Obesity. 2025 Feb 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572122/
- Background: PubMed 22097676Henry FJ. Obesity prevention: the key to non-communicable disease control. West Indian Med J. 2011 Jul;60(4):446-51.
- Background: PubMed 34103067Liang X, Zhang P, Luo S, Zhang G, Tang X, Liu L. The association of quality of life and personality characteristics with adolescent metabolic syndrome: a cohort study. Health Qual Life Outcomes. 2021 Jun 8;19(1):160. doi: 10.1186/s12955-021-01797-7.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Ghada om El-sedaffy, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Disorders in Children, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa sh Abd Elalem, doctor (0201063853481, mostafa.shawky.1121984@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
screening tool for metabolic syndrome (time frame: At recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05681104, which also lists 4 linked publications.
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 31 Oct 2023.