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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06448858
Other study ID # Minerals in Adolescent
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date June 2025

Study information

Verified date June 2024
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Evaluation of the concentration of serum Mn, Se, iron, Cu & Zn levels in obese and overweight adolescents, Correlate the body composition parameters with these minerals' concentration, Study the association between the metabolic risk factors and the disturbance in minerals levels in these patients.


Description:

Obesity in the population tends to be a notable public health threat on the global scale . individuals with higher body mass index (BMI) are considered to have a lower life expectancy . Among the obesity-related indicators, visceral adipose tissue (VAT) is acknowledged an emerging and sensitive predictor for the risk of metabolic syndrome and cardiovascular disease . Therefore, adverse VAT accumulation can influence metabolic health in the population, and its related risk factors should be further investigated. Micronutrients in obese people are explored because of an excess energy consumption, and therefore, an inadequate intake of trace elements and minerals. This imbalance among energy consumption and the intake is known as hidden hunger. Obesity can lead to nutritional metabolic disorders, in which the general state of trace elements and minerals are altered. Only a few studies on child and adolescents obesity concerned Trace Elements (TE). TE is involved in the pathogenesis of obesity and obesity related diseases. We tried to assess trace elements status [ Manganese (Mn), selenium (Se) copper (Cu),zinc (Zn)] in obese children and their relationships with VAT and metabolic risk factors of obesity. Manganese (Mn) is an essential trace element . It plays an important role in fat metabolism. Selenium (Se) is an essential micronutrient that acts as an antioxidant and possesses multiple metabolic properties. Copper (Cu) is a trace element that is vital. Cu has been reported to play a role in fat metabolism. Zinc (Zn) plays an important role. Its deficiency impairs growth, metabolism and immunity. Iron (Fe) is an essential trace element to sustain all forms of life. Existing research indicates iron deficiency is one of the comorbidities associated with obesity .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 84
Est. completion date June 2025
Est. primary completion date May 2025
Accepts healthy volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility Inclusion Criteria: 1. Patients in adolescent age (12-18 years old) 2. Patients with BMI over 25. Exclusion Criteria: 1. Patients younger than 12 years old or older than 18 years old. 2. Patients with history of chronic use of mineral and /or vitamin supplements . 3. Patients with syndromal obesity , endocrine disorder and history of any chronic diseases , 4. Patients under special diets or chronic use of medication .

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
serum Mn, Se, iron, Cu & Zn levels
Evaluate the concentration of serum Mn, Se, iron, Cu & Zn levels in obese and overweight adolescents.

Locations

Country Name City State
Egypt Assiut university hospital Assiut Governorate

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary concentration of serum Manganese Evaluate the concentration of serum Mn levels in obese and overweight adolescents. 1 year
Primary Concentration of serum selenium Evaluate the concentration of serum Se levels in obese and overweight adolescents. 1 year
Primary Concentration of serum Iron Evaluate the concentration of serum Iron levels in obese and overweight adolescents. 1 year
Primary Concentration of serum copper Evaluate the concentration of serum Cu levels in obese and overweight adolescents. 1 year
Primary Concentration of serum Zinc Evaluate the concentration of serum Zn levels in obese and overweight adolescents. 1 year
Secondary BMI and its relation to mineral levels Correlate the BMI with these minerals' concentration. 1 year
Secondary Visceral fat and it's relation to mineral levels Correlate Visceral fat with these minerals' concentration. 1 year
Secondary Basal metabolic rate and it's relation to mineral levels Correlate basal metabolic rate with these minerals' concentration. 1 year
Secondary Body fat percentage and it's relation to mineral level Correlate body fat percentage with these minerals' concentration. 1 year
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