Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2026-02-20 @ 7:24 PM
Study NCT ID:
NCT06448858
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minerals Status in Relation to Overweight and Obese Adolescent
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2024-05-16', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concentration of serum Manganese', 'timeFrame': '1 year', 'description': 'Evaluate the concentration of serum Mn levels in obese and overweight adolescents.'}, {'measure': 'Concentration of serum selenium', 'timeFrame': '1 year', 'description': 'Evaluate the concentration of serum Se levels in obese and overweight adolescents.'}, {'measure': 'Concentration of serum Iron', 'timeFrame': '1 year', 'description': 'Evaluate the concentration of serum Iron levels in obese and overweight adolescents.'}, {'measure': 'Concentration of serum copper', 'timeFrame': '1 year', 'description': 'Evaluate the concentration of serum Cu levels in obese and overweight adolescents.'}, {'measure': 'Concentration of serum Zinc', 'timeFrame': '1 year', 'description': 'Evaluate the concentration of serum Zn levels in obese and overweight adolescents.'}], 'secondaryOutcomes': [{'measure': 'BMI and its relation to mineral levels', 'timeFrame': '1 year', 'description': "Correlate the BMI with these minerals' concentration."}, {'measure': "Visceral fat and it's relation to mineral levels", 'timeFrame': '1 year', 'description': "Correlate Visceral fat with these minerals' concentration."}, {'measure': "Basal metabolic rate and it's relation to mineral levels", 'timeFrame': '1 year', 'description': "Correlate basal metabolic rate with these minerals' concentration."}, {'measure': "Body fat percentage and it's relation to mineral level", 'timeFrame': '1 year', 'description': "Correlate body fat percentage with these minerals' concentration."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mineral Deficiency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.nature.com/articles/s41574-019-0176-8', 'label': 'Bluher M. Obesity: Global epidemiology and pathogenesis. Nat. Rev. Endocrinol. 2019;15:288-298. doi: 10.1038/s41574-019-0176-8. \\[PubMed\\] \\[CrossRef\\] \\[Google Scholar\\]'}, {'url': 'https://www.bmj.com/content/372/bmj.n365.short', 'label': 'Liu B., Du Y., Wu Y., Snetselaar L.G., Wallace R.B., Bao W. Trends in obesity and adiposity measures by race or ethnicity among adults in the United States 2011-18: Population based study. BMJ. 2021;372:n365. doi: 10.1136/bmj.n365. \\[PMC free article\\] \\['}, {'url': 'https://www.bmj.com/content/368/bmj.l6669.abstract', 'label': 'Li Y., Schoufour J., Wang D.D., Dhana K., Pan A., Liu X., Song M., Liu G., Shin H.J., Sun Q., et al. Healthy lifestyle and life expectancy free of cancer, cardiovascular disease, and type 2 diabetes: Prospective cohort study. BMJ. 2020;368:l6669. doi:'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nMicronutrients 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.\n\nOnly 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.\n\nManganese (Mn) is an essential trace element . It plays an important role in fat metabolism.\n\nSelenium (Se) is an essential micronutrient that acts as an antioxidant and possesses multiple metabolic properties.\n\nCopper (Cu) is a trace element that is vital. Cu has been reported to play a role in fat metabolism.\n\nZinc (Zn) plays an important role. Its deficiency impairs growth, metabolism and immunity.\n\nIron (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 .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normal,overweight and obese adolescents', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients in adolescent age (12-18 years old)\n2. Patients with BMI over 25.\n\nExclusion Criteria:\n\n1. Patients younger than 12 years old or older than 18 years old.\n2. Patients with history of chronic use of mineral and /or vitamin supplements .\n3. Patients with syndromal obesity , endocrine disorder and history of any chronic diseases ,\n4. Patients under special diets or chronic use of medication .'}, 'identificationModule': {'nctId': 'NCT06448858', 'briefTitle': 'Minerals Status in Relation to Overweight and Obese Adolescent', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Body Composition on Some Blood Minerals Status in Obese and Overweight Adolescent; Cross Sectional Study', 'orgStudyIdInfo': {'id': 'Minerals in Adolescent'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obese', 'description': 'Patients with BMI more than 30', 'interventionNames': ['Diagnostic Test: serum Mn, Se, iron, Cu & Zn levels']}, {'label': 'Overweight', 'description': 'Patients with BMI 25-30', 'interventionNames': ['Diagnostic Test: serum Mn, Se, iron, Cu & Zn levels']}, {'label': 'Control', 'description': 'Patients with BMI less than 25', 'interventionNames': ['Diagnostic Test: serum Mn, Se, iron, Cu & Zn levels']}], 'interventions': [{'name': 'serum Mn, Se, iron, Cu & Zn levels', 'type': 'DIAGNOSTIC_TEST', 'description': 'Evaluate the concentration of serum Mn, Se, iron, Cu \\& Zn levels in obese and overweight adolescents.', 'armGroupLabels': ['Control', 'Obese', 'Overweight']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'state': 'Governorate', 'country': 'Egypt', 'facility': 'Assiut university hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident doctor', 'investigatorFullName': 'Dalia Hussien Abdelmoneim Hassan', 'investigatorAffiliation': 'Assiut University'}}}}