Detection of Pre-Diabetes in Overweight and Obese Children

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06117358
Collaborator
(none)
100
16.5

Study Details

Study Description

Brief Summary

Descriptive cross section study To detect prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Childhood obesity has reached epidemic levels in developed as well as in developing countries, Overweight and obesity in childhood have significant impact on both physical and psychological health.

    Childhood obesity has been linked to numerous medical conditions. These conditions include :

    fatty liver disease, sleep apnea, Type 2 diabetes, asthma, cardiovascular disease, high cholesterol, cholelithiasis (gallstones), glucose intolerance and insulin resistance, etc.

    Obesity is associated with Prediabetes , a significant risk factor for development of type 2 diabetes mellitus T2DM and its accompanying complications.

    In some populations, type 2 diabetes is now the dominant form of diabetes in children and adolescents.

    Prediabetes is defined by a fasting glucose level of 100 to 125 mg/dL , glycated hemoglobin level (HbA1C) of 5.7% to 6.4% , or a glucose level of 140 to 199 mg/dL measured 2 hours after a 75-g oral glucose load. approximately 10% of people with prediabetes progress to having diabetes each year.

    The vast majority of pediatric cases occur after age 10, with the peak age for presentation occurring at mid-puberty (approximately age 14 years).

    The ADA recommends screening for type 2 diabetes in children after onset of puberty or age 10 years who are overweight (BMI ≥85th percentile) or obese (BMI ≥95th percentile) and have one or more additional risk factors for diabetes.

    One report in JAMA Pediatrics found that nearly one in three adolescents and teens has prediabetes and the rate among 12 to 19 year-olds more than doubled between 1999-2002 and 2015-2018, jumping from 12 percent to 28 percent.

    However , no enough data are available regarding prevalence and risk factors of prediabetes in overweight and obese youth particularly in our locality.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Detection of Pre-Diabetes in Overweight and Obese Children and Adolescents in Assiut Governorate
    Anticipated Study Start Date :
    Nov 15, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Mar 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of Pre-Diabetes in Overweight and Obese children and adolescents in Assiut governorate [Baseline]

      determine the prevalence of prediabetes in overweight and obese children and adolescents in Assiut Governorate and to find out the possible risk factors through many investigations as HbA1c , Fasting blood glucose level , Lipid profile in 150 obese children.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Both sexes , aged (10-18) years.

    • Body mass index calculated as weight in Kg/(height in meters)2 :

    • Over weight > 85% percentile

    • Obese > 95% percentile " On Egyptian growth chart "

    Exclusion Criteria:
    • • Children and adolescents with type 2 diabetes mellitus.

    • Children and adolescents with drug history affecting blood glucose level as corticosteroids.

    • Children and adolescents with any condition affecting blood glucose level as Cushing disease.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmoud Bakr Gaber, Principal Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT06117358
    Other Study ID Numbers:
    • Detection of Pre-Diabetes
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 7, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 7, 2023