Pediatric ObesityNCT07859657
Cardiovascular Alterations in Obese Children
An observational study of Pediatric Obesity, run by Assiut University.
Trial summary
This cross-sectional study aims to assess cardiovascular structural and electrophysiological alterations in obese children attending Assiut University Children's Hospital. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pediatric Obesity
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 2 Oct 2026to 1 Mar 2028
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents aged 1 to 18 years with obesity (BMI ≥95th percentile for age and sex) attending Assiut University Children's Hospital.
Who may be able to join
- - Age 1 to 18 years
- Body mass index ≥95th percentile for age and sex
- No previously diagnosed structural heart disease
- No known primary cardiac rhythm or conduction disorder
- Written informed consent from parent or legal guardian
Who cannot join
- - Known structural heart disease
- Known cardiac arrhythmia or conduction abnormality
- Diabetes mellitus
- Hypertension requiring treatment
- Hypothyroidism or other endocrine disorders affecting cardiac function
- Chronic renal, hepatic, respiratory, or systemic disease
Show all 11Show fewer
- Pulmonary hypertension
- Obstructive sleep apnea
- Medications known to affect cardiac rhythm or function
- Electrolyte abnormalities
- Acute significant illness at the time of assessment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cardiovascular Structural and Electrophysiological Alterations in Obese Children Attending Assiut University Children's Hospital
This cross-sectional study aims to assess cardiovascular structural and electrophysiological alterations in obese children attending Assiut University Children's Hospital.
Read the detailed description
Childhood obesity is associated with early cardiovascular structural and electrophysiological changes. This observational study will evaluate left ventricular structure and function by echocardiography and electrocardiographic parameters including P-wave duration and dispersion in children and adolescents with obesity aged 1 to 18 years.
- Conditions
- Pediatric Obesity
- Keywords
- Obesity, Echocardiography, Electrocardiography, Left ventricular mass, P-wave dispersion, Assiut, Children
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese Children | Children and adolescents aged 1 to 18 years with body mass index ≥95th percentile for age and sex attending Assiut University Children's Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean left ventricular mass index
Mean left ventricular mass index measured by echocardiography in g/m².
Measured: Baseline
Secondary outcomes (5)
Mean P-wave dispersion
Mean P-wave dispersion measured on 12-lead electrocardiogram in milliseconds.
Measured: Baseline
Mean corrected QT interval
Mean corrected QT interval (QTc) measured on 12-lead electrocardiogram in milliseconds.
Measured: Baseline
Mean E/A ratio
Mean early to late diastolic filling velocity ratio (E/A ratio) measured by pulsed-wave Doppler echocardiography.
Measured: Baseline
Mean left ventricular wall thickness
Mean left ventricular wall thickness measured by echocardiography in millimeters.
Measured: Baseline
Mean body mass index
Mean body mass index in kg/m².
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start2 Oct 2026 (estimated)
- Primary completion10 Oct 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Hussein, Assiut University
- Investigators
- Faisel E Ahmed, prof, Study chair, Pediatrics Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859657
- Sponsor's protocol ID
- Obesity-CV-Assiut-2026
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Structural and Electrophysiological Alterations in Obese Children Attending Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT07859657
- Acronym / sponsor ID
- Obesity-CV-Assiut-2026
- Conditions
- Pediatric Obesity
- Keywords
- Obesity, Echocardiography, Electrocardiography, Left ventricular mass, P-wave dispersion, Assiut, Children
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 6 Oct 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.
This cross-sectional study aims to assess cardiovascular structural and electrophysiological alterations in obese children attending Assiut University Children's Hospital.
Detailed description
Childhood obesity is associated with early cardiovascular structural and electrophysiological changes. This observational study will evaluate left ventricular structure and function by echocardiography and electrocardiographic parameters including P-wave duration and dispersion in children and adolescents with obesity aged 1 to 18 years.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese Children | – | –Children and adolescents aged 1 to 18 years with body mass index ≥95th percentile for age and sex attending Assiut University Children's Hospital. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged 1 to 18 years with obesity (BMI ≥95th percentile for age and sex) attending Assiut University Children's Hospital.
Key inclusion criteria (5 listed)
- - Age 1 to 18 years
- Body mass index ≥95th percentile for age and sex
- No previously diagnosed structural heart disease
- No known primary cardiac rhythm or conduction disorder
- Written informed consent from parent or legal guardian
Key exclusion criteria (11 listed)
- - Known structural heart disease
- Known cardiac arrhythmia or conduction abnormality
- Diabetes mellitus
- Hypertension requiring treatment
- Hypothyroidism or other endocrine disorders affecting cardiac function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean left ventricular mass index
Time frame: Baseline
Mean left ventricular mass index measured by echocardiography in g/m².
5 secondary outcomes
Mean P-wave dispersion
Time frame: Baseline
Mean corrected QT interval
Time frame: Baseline
Mean E/A ratio
Time frame: Baseline
Mean left ventricular wall thickness
Time frame: Baseline
Mean body mass index
Time frame: Baseline
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 6 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Faisel E Ahmed, prof study chair
Pediatrics Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity, 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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 6 Oct 2026. 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?
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 Mohamed A Mohamed, Resident (+20 10 30046583, mohamedmnr949@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean left ventricular mass index (time frame: Baseline). 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 6 Oct 2026.