Detection of Pre-Diabetes in Overweight and Obese Children

Pre-Diabetes Clinical Trial

Official title:

Detection of Pre-Diabetes in Overweight and Obese Children and Adolescents in Assiut Governorate

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117358
• Other study ID #: Detection of Pre-Diabetes
• Status: Not yet recruiting
• Start date: November 15, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Mahmouud Bakr
• Phone: +201067094097
• Email: mahmoudbakr423[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Overweight
• Pre-Diabetes
• Prediabetic State

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Pre-Diabetes in Overweight and Obese children and adolescents in Assiut governorate	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.	Baseline