Children With Simple ObesityNCT07174518
Hormonal Impalance in Children With Simple Obesity
An observational study of Children With Simple Obesity, run by Assiut University.
Trial summary
Obesity in children and adolescents is a global health issue with increasing prevalence in low and middle-income countries (LMICs) as well as a high prevalence in many high-income countries. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Children With Simple Obesity
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Nov 2026
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents aged 5 to 18 years diagnosed to be have simple obesity which it refers to excessive weight gain resulting from chronic imbalance between energy intake and energy expenditure specifically when child consumes more calories than the body uses over time with Body Mass Index (BMI) ≥ 95 th percentile on CDC growth chart
Who may be able to join
- Children and adolescents aged 5 to 18 years diagnosed to be have simple obesity which it refers to excessive weight gain resulting from chronic imbalance between energy intake and energy expenditure specifically when child consumes more calories than the body uses over time with Body Mass Index (BMI) ≥ 95 th percentile on CDC growth chart
Who cannot join
- Any obese child with:
- Endocrinal diseases.
- Syndromic obesity.
About this study
Obesity in children and adolescents is a global health issue with increasing prevalence in low and middle-income countries (LMICs) as well as a high prevalence in many high-income countries. Obesity during INTRODUCTION
childhood is likely to continue into adulthood and is associated with cardiometabolic and psychosocial comorbidity as well as premature mortality. [1] WHO defines overweight and obesity as an abnormal or excessive fat accumulation that presents a risk to health. BMI (weight/height2; kg/m2) is used as an indirect measure of body fatness in children and adolescents and should be compared with population growth references adjusted for sex and age.[2] The WHO Growth Standard is recommended in many countries for children aged 0-5 years, and for those aged 5-19 years (overweight defined as BMI ≥1SD and obesity as BMI ≥2SD of the median for age and sex), and the United States Centers for Disease Control and Prevention (CDC) Growth Reference for those aged 2 to 20 years (overweight is >85th to <95th percentile and obesity is ≥95th percentile based on CDC growth charts). [3] Abdominal or central obesity is associated with increased cardiometabolic risk in children and adolescents. For waist circumference there are regional and international growth references allowing adjustment for age and sex. A waist-to-height ratio of more than 0·5 is increasingly used as an indicator of abdominal adiposity.[4] Simple obesity, also known as primary obesity, is the most common type of obesity seen in children and adolescents. It refers to excessive weight gain resulting from a chronic imbalance between energy intake and energy expenditure, specifically when the child consumes more calories than the body uses over time.[5] Simple obesity tends to develop progressively, although it is not initially caused by endocrine dysfunction, chronic excessive adiposity may contribute to hormonal imbalances and metabolic consequences over time. These include insulin resistance, early onset of puberty, and dysregulation in the levels of key adipokines such as leptin and adiponectin. [6] It is established that excess adipose tissue can lead to significant hormonal disturbances. Adipose tissue functions as an active endocrine organ, secreting various adipokines and inflammatory mediators that disrupt normal metabolic and hormonal homeostasis.[7] One of the earliest and most critical alterations is insulin resistance, often accompanied by hyperinsulinemia. This state increases the risk of glucose intolerance and type 2 diabetes. Additionally, obese children typically exhibit leptin resistance, where elevated leptin levels fail to suppress appetite, contributing to continued weight gain. Conversely, adiponectin levels are often reduced, further impairing insulin sensitivity and promoting metabolic syndrome.[8] Obesity-related stress and inflammation can also dysregulate the hypothalamic-pituitary-adrenal (HPA) axis, leading to altered cortisol secretion, which promotes central fat accumulation and influences appetite and mood. Furthermore, obesity may affect the hypothalamic-pituitary- gonadal (HPG) axis, resulting in early puberty in girls and sometimes delayed puberty in boys, along with imbalances in sex hormones.[9]
- Conditions
- Children With Simple 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 |
|---|---|---|
| study group | Children and adolescents aged 5 to 18 years diagnosed to be have simple obesity which it refers to excessive weight gain resulting from chronic imbalance between energy intake and energy expenditure specifically when child consumes more calories than the body uses over time with Body Mass Index (BMI) ≥ 95 th percentile on CDC growth chart |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidance of hormonal imbalance in children with simple obesity
evaluate hormonal imbalance in children with simple obesity
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Simple 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
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Ragab Hashem Abdalla, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174518
- Sponsor's protocol ID
- Hormonal impalance in obesity
- Status last verified
- Sep 2025
- First submitted
- 11 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hormonal Impalance in Children With Simple Obesity
- ClinicalTrials.gov ID
- NCT07174518
- Acronym / sponsor ID
- Hormonal impalance in obesity
- Conditions
- Children With Simple Obesity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 16 Sep 2025 (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.
Obesity in children and adolescents is a global health issue with increasing prevalence in low and middle-income countries (LMICs) as well as a high prevalence in many high-income countries. Obesity during INTRODUCTION
childhood is likely to continue into adulthood and is associated with cardiometabolic and psychosocial comorbidity as well as premature mortality. [1] WHO defines overweight and obesity as an abnormal or excessive fat accumulation that presents a risk to health. BMI (weight/height2; kg/m2) is used as an indirect measure of body fatness in children and adolescents and should be compared with population growth references adjusted for sex and age.[2] The WHO Growth Standard is recommended in many countries for children aged 0-5 years, and for those aged 5-19 years (overweight defined as BMI ≥1SD and obesity as BMI ≥2SD of the median for age and sex), and the United States Centers for Disease Control and Prevention (CDC) Growth Reference for those aged 2 to 20 years (overweight is >85th to <95th percentile and obesity is ≥95th percentile based on CDC growth charts). [3] Abdominal or central obesity is associated with increased cardiometabolic risk in children and adolescents. For waist circumference there are regional and international growth references allowing adjustment for age and sex. A waist-to-height ratio of more than 0·5 is increasingly used as an indicator of abdominal adiposity.[4] Simple obesity, also known as primary obesity, is the most common type of obesity seen in children and adolescents. It refers to excessive weight gain resulting from a chronic imbalance between energy intake and energy expenditure, specifically when the child consumes more calories than the body uses over time.[5] Simple obesity tends to develop progressively, although it is not initially caused by endocrine dysfunction, chronic excessive adiposity may contribute to hormonal imbalances and metabolic consequences over time. These include insulin resistance, early onset of puberty, and dysregulation in the levels of key adipokines such as leptin and adiponectin. [6] It is established that excess adipose tissue can lead to significant hormonal disturbances. Adipose tissue functions as an active endocrine organ, secreting various adipokines and inflammatory mediators that disrupt normal metabolic and hormonal homeostasis.[7] One of the earliest and most critical alterations is insulin resistance, often accompanied by hyperinsulinemia. This state increases the risk of glucose intolerance and type 2 diabetes. Additionally, obese children typically exhibit leptin resistance, where elevated leptin levels fail to suppress appetite, contributing to continued weight gain. Conversely, adiponectin levels are often reduced, further impairing insulin sensitivity and promoting metabolic syndrome.[8] Obesity-related stress and inflammation can also dysregulate the hypothalamic-pituitary-adrenal (HPA) axis, leading to altered cortisol secretion, which promotes central fat accumulation and influences appetite and mood. Furthermore, obesity may affect the hypothalamic-pituitary- gonadal (HPG) axis, resulting in early puberty in girls and sometimes delayed puberty in boys, along with imbalances in sex hormones.[9]
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –Children and adolescents aged 5 to 18 years diagnosed to be have simple obesity which it refers to excessive weight gain resulting from chronic imbalance between energy intake and energy expenditure specifically when child consumes more calories than the body uses over time with Body Mass Index (BMI) ≥ 95 th percentile on CDC growth chart |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents aged 5 to 18 years diagnosed to be have simple obesity which it refers to excessive weight gain resulting from chronic imbalance between energy intake and energy expenditure specifically when child consumes more calories than the body uses over time with Body Mass Index (BMI) ≥ 95 th percentile on CDC growth chart
Key inclusion criteria (1 listed)
- Children and adolescents aged 5 to 18 years diagnosed to be have simple obesity which it refers to excessive weight gain resulting from chronic imbalance between energy intake and energy expenditure specifically when child consumes more calories than the body uses over time with Body Mass Index (BMI) ≥ 95 th percentile on CDC growth chart
Key exclusion criteria (3 listed)
- Any obese child with:
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
incidance of hormonal imbalance in children with simple obesity
Time frame: baseline
evaluate hormonal imbalance in children with simple obesity
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 16 Sep 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Children With Simple 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 1 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: opening soon, as of the sponsor's last update on 16 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidance of hormonal imbalance in children with simple obesity (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 16 Sep 2025.