Early Detection of Metabolic Syndrome and Obesity Comorbidities

October 27, 2023 updated by: Mostafa Shawky Ibrahim Abd Elalem, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Obese children (Body mass index >95th percentile) aged 6-12 years old

Description

Inclusion Criteria:

  • Obese children (Body mass index >95th percentile) aged 6-12 years old

Exclusion Criteria:

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 )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
metabolic syndrome diagnostic tool
Time Frame: At recruitment
Body mass index as an early predictors of metabolic syndrome in primary school obese children
At recruitment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
screening tool
Time Frame: At recruitment
waist-height ratio as an early predictors of metabolic syndrome in primary school obese children
At recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ghada om El-sedaffy, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 29, 2022

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • metabolic syndrome in children

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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