Ignite Creation Date:
2025-12-24 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 5:12 AM
Study NCT ID:
NCT02495961
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2015-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Chronic Degenerative Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006943', 'term': 'Hyperglycemia'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D020138', 'term': 'Hyperhomocysteinemia'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000592', 'term': 'Amino Acid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D014804', 'term': 'Vitamin B Deficiency'}, {'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-15', 'studyFirstSubmitDate': '2015-07-09', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic syndrome component detection', 'timeFrame': 'six months', 'description': 'After six months of a basal evaluation, children will be re-examined in each component of the metabolic syndrome.\n\nMetabolic syndrome component detection will be determined by the measure of glucose (mg/dl), cholesterol (mg/dl), triglycerides (mg/dl), high-density lipoproteins (HDL), waist circumference (cm), hip circumference (cm) and blood pressure (mmHg).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyperlipidemias', 'hyperglycemia', 'hypertension', 'leptin', 'hyperhomocysteinemia'], 'conditions': ['Metabolic Syndrome X']}, 'descriptionModule': {'briefSummary': "The prevalence of obesity and type 2 diabetes mellitus (DM) in children have been increasing in parallel at an alarming rate. In particular, the increasing prevalence of type 2 DM is attributable to genetic factors, clinical (waist circumference, adiposity and physical condition) and biochemical (insulin secretion and sensitivity, lipids and inflammation) risk, each of which represents an independent risk.\n\nAs has already studied and published in the investigators' group, the child population of Toluca has greater expression of cardiovascular risk factors than their counterparts in Bogota, Colombia. The metabolic characterization of the young population of Toluca and Bogota with new biomarkers such as homocysteine and leptin is an activity that aims to provide more metabolic data affecting young people.\n\nHypothesis:\n\nAfter six months of follow-up there will be a greater relative risk in Mexican population to have identified another component of metabolic syndrome compared to the young population of Colombia.", 'detailedDescription': "Objective:\n\nTo compare the expression levels of cardiovascular risk markers in young people between 5 and 12 years of Toluca, Mexico and Bogota, Colombia.\n\nMaterial and methods:\n\nType of study: prospective, descriptive, comparative, and longitudinal.\n\nSample Calculation:\n\nFor a cohort study and taking into account that in the investigators' previous publication in the Colombian population only 13% (sick rate in unexposed group) had an altered metabolic parameter; accepting an alpha risk of 0.05 and a beta of 0.2 on a risk bilateral contrast, 57 subjects were required in the exposed group (Mexican population) and 57 in unexposed to detect a minimum relative risk of 3 to find other alteration to metabolic syndrome after six months follow-up.\n\nMeasurements:\n\nThe International Physical Activity Questionnaire (IPAQ) will be applied to all children. Dietary history of three days and physical examination (height in cm , weight in kg and waist circumference in centimeters) and blood pressure (mmHg) data will be recorded. Blood samples will be taken to analyze glucose, cholesterol, HDL, triglycerides, homocysteine and leptin.\n\nStatistics:\n\nVariables will be tested for normality through the Kolmogorov-Smirnov and Shapiro-Wilk formulas. Variables related to the physiological and metabolic functions and anthropometric measurements will be reported in mean and standard deviation. The differences in the laboratorial and anthropometrical variables will be analyzed with the Student t test. A difference will be considered significant with a p value ≤ 0.05. The statistical program used is the Statistical Package for the Social Sciences (SPSS) version 19."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Primary school students.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary school students of medium-low income.\n\nExclusion Criteria:\n\n* Children with disabilities or a known chronic disease.'}, 'identificationModule': {'nctId': 'NCT02495961', 'briefTitle': 'Study of Chronic Degenerative Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Asociación Científica Latina A.C.'}, 'officialTitle': 'Study of Chronic Degenerative Diseases, Translational Medicine Approach', 'orgStudyIdInfo': {'id': '2014-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Low risk population', 'description': 'Colombian children, between 6 and 12 years old, regular students of a Primary school.'}, {'label': 'High risk population', 'description': 'Mexican children, between 6 and 12 years old, regular students of a Primary school.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50120', 'city': 'Toluca', 'state': 'State of Mexico', 'country': 'Mexico', 'facility': 'Asociación Científica Latina A.C.', 'geoPoint': {'lat': 19.28786, 'lon': -99.65324}}], 'overallOfficials': [{'name': 'Hugo Mendieta Zerón, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociación Científica Latina A.C.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asociación Científica Latina A.C.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidad Autonoma del Estado de Mexico', 'class': 'OTHER'}, {'name': 'Ciprés Grupo Médico CGM SC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}