Prevalence of IR in Overweight and Obese Adolescents (IR)

April 26, 2023 updated by: Yara Mostafa, Assiut University

Prevalence and Risk Factors of Insulin Resistance in Overweight and Obese Adolescents

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

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

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adolescent Children attending Hospital or Primary care clinics in Egypt whom fit the criteria.

Description

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 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

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants of the Obese or Overweight category with elevated Serum Fasting Insulin and Serum Fasting glucose scores
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identifying Risk Factors for Insulin Resistance in each group
Time Frame: 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.
Baseline

Collaborators and Investigators

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

Sponsor

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 (Anticipated)

May 11, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

August 30, 2025

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR in Overweight Adolescents

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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