Prevalence of IR in Overweight and Obese Adolescents

Not yet recruiting

• Conditions: Insulin Resistance
• Interventions: Diagnostic Test: Blood Tests; Serum Fasting Insulin and Glucose

• Registration Number: NCT05810883
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-12
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-11
• Study First Posted: 2023-04-13
• Last Update Submitted: 2023-04-26
• Last Update Posted: 2023-04-28
• Study Start: 2023-05-11
• Primary Completion: 2024-02-01
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Insulin Resistant	Blood Tests; Serum Fasting Insulin and Glucose	HOMA-IR score of less than 3.4
Insulin Resistant Group	Blood Tests; Serum Fasting Insulin and Glucose	HOMA-IR score of ≥ 3.4

Primary Outcome Measures

Name	Time	Method
Number of participants of the Obese or Overweight category with elevated Serum Fasting Insulin and Serum Fasting glucose scores	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, higher scores indicating increased Insulin Resistance.

Secondary Outcome Measures

Name	Time	Method
Identifying Risk Factors for Insulin Resistance in each group	Baseline	Information on each individual gathered regarding Lifestyle and Nutritional Habits including Social/Economic condition, Family History for obesity, diabetes and hypertension, perinatal history, early feeding and detailed Nutritional History; including sugar, carbohydrate and fat consumption, Physical activity, sleep quality, psychological stressors and performance at school. Data will be gathered for each group; Insulin Resistant and Non-Insulin resistance to determine associations between the two.