Clinical trial NCT05798676: Maternal Characteristics Associated With Child Growth and Adiposity
Official title: Maternal Characteristics Associated With Child Growth and Adiposity. Search for Nutrigenomic Biomarkers in Peripheral Blood
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Obesity, Infant
Lead sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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/obesity. The main question\[s\] it aims to answer are:

* Are maternal hormones associated with child growth and adiposity
* Are maternal hormone receptors associated with child growth and adiposity
* Are infant hormones and their receptors associated with child growth and adiposity Participants will provide milk and blood samples. Researchers will compare mothers with normal weight and with pre-pregnancy overweight/obesity to see if there are differences in child growth and adiposity .


Eligibility criteria: Inclusion Criteria:

* Lactating women with pre-pregnancy normal weight and overweight or obesity as described by the World Health Organization.

Exclusion Criteria:

* Diabetes (Type I or II or gestational)
* Multiple pregnancy
* Hypertensive disorders during pregnancy
* Delivery of pre-term infant (\<37 weeks).

Primary outcomes:
measure: infant weight
timeFrame: from birth to 2 years old
measure: infant height
timeFrame: from birth to 2 years old
measure: infant body mass index (BMI)
timeFrame: from birth to 2 years old
measure: infant upper arm circumference
timeFrame: from birth to 2 years old
measure: infant skinfold thickness
timeFrame: from birth to 2 years old
measure: infant blood leptin concentration
timeFrame: six months old
measure: infant blood cortisol concentration
timeFrame: six months old
measure: infant saliva cortisol concentration
timeFrame: six months old
measure: infant blood insulin concentration
timeFrame: six months old
measure: infant insulin receptor gene expression in peripheral blood mononuclear cells
timeFrame: six months old
measure: infant leptin receptor gene expression in peripheral blood mononuclear cells
timeFrame: six months old
measure: infant glucocorticoid receptor gene expression in peripheral blood mononuclear cells
timeFrame: six months old
measure: infant blood LEAP2 concentration
timeFrame: six months old
Secondary outcomes:
measure: maternal blood leptin concentration
timeFrame: 15 days, three and six months postpartum
measure: maternal milk leptin concentration
timeFrame: 15 days, three and six months postpartum
measure: maternal blood insulin concentration
timeFrame: 15 days, three and six months postpartum
measure: maternal milk insulin concentration
timeFrame: 15 days, three and six months postpartum
measure: maternal blood cortisol concentration
timeFrame: 15 days, three and six months postpartum
measure: maternal milk cortisol concentration
timeFrame: 15 days, three and six months postpartum
measure: maternal insulin receptor gene expression in peripheral blood mononuclear cells
timeFrame: 15 days, three and six months postpartum
measure: maternal leptin receptor gene expression in peripheral blood mononuclear cells
timeFrame: 15 days, three and six months postpartum
measure: maternal glucocorticoid receptor gene expression in peripheral blood mononuclear cells
timeFrame: 15 days, three and six months postpartum
measure: maternal blood LEAP2 concentration
timeFrame: 15 days, three and six months postpartum
measure: maternal milk LEAP2 concentration
timeFrame: 15 days, three and six months postpartum
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
state: Buenos Aires
Study officials:
affiliation: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
name: Maria F Andreoli, BsC
role: PRINCIPAL_INVESTIGATOR
References: