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Prevalence of IR in Overweight and Obese Adolescents

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05810883
Collaborator
(none)
50
Enrollment
27.7
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The aim of this study is to determine the prevalence of Insulin Resistance (IR) among overweight and obese adolescents using HOMA-IR scores and identify lifestyle risk factors in the IR and Non-IR group.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood Tests; Serum Fasting Insulin and Glucose

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prevalence and Risk Factors of Insulin Resistance in Overweight and Obese Adolecents
Anticipated Study Start Date :
May 11, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Aug 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Insulin Resistant Group

HOMA-IR score of ≥ 3.4

Diagnostic Test: Blood Tests; Serum Fasting Insulin and Glucose
Laboratory results of blood samples, for high-density lipoprotein (HDL), low-density protein (LDL), triglycerides, and total cholesterol (TC) will be evaluated for this study. Fasting Insulin and fasting glucose levels will be used to calculate IR. Insulin Resistance will be calculated using Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (FPG (mmol/L) × FPI (mU/L)/22.5) [21] and defined as HOMA-IR ≥ 3.4
Other Names:
  • Anthropometric Measurements including BMI and Waist circumference

    		•
    Non-Insulin Resistant

    HOMA-IR score of less than 3.4

    Diagnostic Test: Blood Tests; Serum Fasting Insulin and Glucose
    Laboratory results of blood samples, for high-density lipoprotein (HDL), low-density protein (LDL), triglycerides, and total cholesterol (TC) will be evaluated for this study. Fasting Insulin and fasting glucose levels will be used to calculate IR. Insulin Resistance will be calculated using Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (FPG (mmol/L) × FPI (mU/L)/22.5) [21] and defined as HOMA-IR ≥ 3.4
    Other Names:
  • Anthropometric Measurements including BMI and Waist circumference

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Prevalence of Insulin Resistance [Baseline]

      Measuring Serum Fasting Insulin and Fasting Glucose levels to calculate HOMA-IR scores Insulin Resistance will be calculated using Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (Fasting Plasma Glucose (mmol/L) × Fasting Plasma Insulin (mU/L)/22.5) and defined as HOMA-IR ≥ 3.4 to Detect Prevalence of IR

    Secondary Outcome Measures

    1. Determining Risk Factors for Insulin Resistance in Adolescents [Baseline]

      Gathering Information on each individual patient regarding Lifestyle and Nutritional Habits, Anthropometric measurements

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Adolescents of ages ≥ 10-≤18 years, of both sexes who are Overweight (BMI > 85th percentile) or Obese (BMI > 95th percentile).
    Exclusion Criteria:
    • Obesity due to Secondary causes as Cushing disease or hypothyroid patients, and any other patients with Chronic illness.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Yara Mostafa, Pediatric Resident Physician, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05810883
    Other Study ID Numbers:
    • IR in Overweight Adolescents
    First Posted:
    Apr 13, 2023
    Last Update Posted:
    Apr 13, 2023
    Last Verified:
    Apr 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Insulin Resistance
    Overweight
    Insulin

    Study Results

    No Results Posted as of Apr 13, 2023