[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100500624":3},{"organization":4,"outcomesModule":7,"designInfo":83,"detailedDescription":82,"studyPopulation":86,"armGroups":87,"interventions":96,"overallOfficials":101,"centralContacts":105,"locations":112,"responsibleParty":131,"collaborators":82,"id":133,"slug":82,"hasResults":134,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":82,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":140,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":82,"studyType":146,"phases":82,"briefSummary":147,"conditions":148,"keywords":82,"overallStatus":114,"whyStopped":82,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":54,"otherOutcomes":82},[9,13,16,19,22,25,29,32,35,38,41,44,47,50],{"measure":10,"description":11,"timeFrame":12},"infant weight","weight in kilograms","from birth to 2 years old",{"measure":14,"description":15,"timeFrame":12},"infant height","height in centimeters",{"measure":17,"description":18,"timeFrame":12},"infant body mass index (BMI)","weight and height will be combined to report BMI in kg\u002Fm\\^2",{"measure":20,"description":21,"timeFrame":12},"infant upper arm circumference","upper arm circumference in centimeters",{"measure":23,"description":24,"timeFrame":12},"infant skinfold thickness","skinfold thickness in centimeters",{"measure":26,"description":27,"timeFrame":28},"infant blood leptin concentration","blood leptin concentration (ng\u002Fml)","six months old",{"measure":30,"description":31,"timeFrame":28},"infant blood cortisol concentration","blood cortisol concentration (ug%)",{"measure":33,"description":34,"timeFrame":28},"infant saliva cortisol concentration","saliva cortisol (ug%)",{"measure":36,"description":37,"timeFrame":28},"infant blood insulin concentration","blood insulin concentration (uU\u002Fml)",{"measure":39,"description":40,"timeFrame":28},"infant insulin receptor gene expression in peripheral blood mononuclear cells","insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)",{"measure":42,"description":43,"timeFrame":28},"infant leptin receptor gene expression in peripheral blood mononuclear cells","leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)",{"measure":45,"description":46,"timeFrame":28},"infant glucocorticoid receptor gene expression in peripheral blood mononuclear cells","glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)",{"measure":48,"description":49,"timeFrame":28},"infant blood LEAP2 concentration","blood LEAP2 concentration (pg\u002Fml)",{"measure":51,"description":52,"timeFrame":53},"infant eating behavior assessed in a Taste acceptance test","Outcome Measures Infant taste acceptance was assessed using two complementary measures: an Ingestion Ratio (IR) and a Liking Ratio (LR). Sweet and fat taste acceptance were evaluated using a lactose solution (0.2 M) and a fat emulsion (3.5% w\u002Fv), respectively, with water used as a reference. During each test, infants were sequentially offered bottles containing water and the tastant. Intake volume was determined by weighing bottles before and after ingestion.\n\nThe IR was calculated as the volume of tastant consumed divided by the total volume of tastant plus water consumed, allowing comparison across infants by accounting for individual differences in sucking behavior.\n\nThe LR was based on a blinded experimenter's assessment of the infant's overall behavioral response using a standardized 5-point scale ranging from strong rejection to strong acceptance. Both ratios ranged from 0 to 1, with 0.5 indicating indifference relative to water.","at 18 month od",[55,58,61,63,66,68,71,73,75,77,79],{"measure":56,"description":27,"timeFrame":57},"maternal blood leptin concentration","15 days, three and six months postpartum",{"measure":59,"description":60,"timeFrame":57},"maternal milk leptin concentration","milk leptin concentration (ng\u002Fml)",{"measure":62,"description":37,"timeFrame":57},"maternal blood insulin concentration",{"measure":64,"description":65,"timeFrame":57},"maternal milk insulin concentration","milk insulin concentration (uU\u002Fml)",{"measure":67,"description":31,"timeFrame":57},"maternal blood cortisol concentration",{"measure":69,"description":70,"timeFrame":57},"maternal milk cortisol concentration","milk cortisol concentration (ug%)",{"measure":72,"description":40,"timeFrame":57},"maternal insulin receptor gene expression in peripheral blood mononuclear cells",{"measure":74,"description":43,"timeFrame":57},"maternal leptin receptor gene expression in peripheral blood mononuclear cells",{"measure":76,"description":46,"timeFrame":57},"maternal glucocorticoid receptor gene expression in peripheral blood mononuclear cells",{"measure":78,"description":49,"timeFrame":57},"maternal blood LEAP2 concentration",{"measure":80,"description":81,"timeFrame":57},"maternal milk LEAP2 concentration","milk LEAP2 concentration (pg\u002Fml)",null,{"allocation":82,"interventionModel":82,"interventionModelDescription":82,"primaryPurpose":82,"observationalModel":84,"timePerspective":85,"maskingInfo":82},"COHORT","PROSPECTIVE","Lactating women with pre-pregnancy normal weight and overweight or obesity recruited at the Mother and Healthy Children Outpatient Service, Instituto de Desarrollo e Investigaciones Pediátricas (IDIP), HIAEP \"Sor María Ludovica\", La Plata, Argentina.",[88,91],{"label":89,"type":82,"description":90,"interventionNames":82},"mothers with pre-pregnancy normal weight and their infants","mothers with pre-pregnancy normal weight according to World Health Organization will provide blood and milk samples",{"label":92,"type":82,"description":93,"interventionNames":94},"mothers with pre-pregnancy overweight or obesity and their infants","mothers with pre-pregnancy overweight or obesity according to World Health Organization will provide blood and milk samples",[95],"Other: overweight\u002Fobesity",[97],{"type":6,"name":98,"description":99,"armGroupLabels":100,"otherNames":82},"overweight\u002Fobesity","the consequences of maternal pregestational overweight\u002Fobesity on infant´s growth and adiposity will be studied",[92],[102],{"name":103,"affiliation":5,"role":104},"Maria F Andreoli, BsC","PRINCIPAL_INVESTIGATOR",[106],{"name":107,"role":108,"phone":109,"phoneExt":110,"email":111},"Maria F Andreoli, PhD","CONTACT","54 221 4535901","1767","mfandreoli@gmail.com",[113],{"facility":5,"status":114,"city":115,"state":116,"zip":117,"country":118,"countryCode":119,"cosmosGeoPoint":120,"geoPoint":125,"contacts":126},"RECRUITING","La Plata","Buenos Aires","1900","Argentina","AR",{"type":121,"coordinates":122},"Point",[123,124],-57.95442,-34.92126,{"lat":124,"lon":123},[127,128],{"name":107,"role":108,"phone":109,"phoneExt":110,"email":111},{"name":129,"role":108,"phone":109,"phoneExt":110,"email":130},"Ana Kruger, BsC","krugluzana@gmail.com",{"type":132,"investigatorFullName":82,"investigatorTitle":82,"investigatorAffiliation":82,"oldNameTitle":82,"oldOrganization":82},"SPONSOR","100500624",false,"NCT05798676","Maternal Characteristics Associated With Child Growth and Adiposity","Maternal Characteristics Associated With Child Growth and Adiposity. Search for Nutrigenomic Biomarkers in Peripheral Blood","Inclusion Criteria:\n\n* Lactating women with pre-pregnancy normal weight and overweight or obesity as described by the World Health Organization.\n\nExclusion Criteria:\n\n* Diabetes (Type I or II or gestational)\n* Multiple pregnancy\n* Hypertensive disorders during pregnancy\n* Delivery of pre-term infant (\\\u003C37 weeks).",true,"FEMALE","18 Years","40 Years",{"count":144,"type":145},130,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to investigate the concentrations of leptin, insulin, liver expressed antimicrobial peptide 2 (LEAP2), and cortisol in plasma and breast milk and their relationship with eating behavior, growth, adiposity and with the levels of these hormones in infants, comparing mothers with normal weight and with pre-pregnancy overweight\u002Fobesity. The main question\\[s\\] it aims to answer are:\n\n* Are maternal hormones associated with child growth and adiposity\n* Are maternal hormone receptors associated with child growth and adiposity\n* Are infant hormones and their receptors associated with child growth and adiposity\n* Are maternal and infant hormones and their receptors associated with child eating behavior Participants will provide milk and blood samples. Researchers will compare mothers with normal weight and with pre-pregnancy overweight\u002Fobesity to see if there are differences in child growth and adiposity .",[149,150],"Obesity","Obesity, Infant","2025-12-19",{"date":153,"type":154},"2025-12-26","ACTUAL",{"date":156,"type":154},"2019-05-02",{"date":158,"type":145},"2028-03",{"name":5,"class":6},1]