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Maternal Characteristics Associated With Child Growth and Adiposity

Maternal Characteristics Associated With Child Growth and Adiposity. Search for Nutrigenomic Biomarkers in Peripheral Blood

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05798676
Enrollment
130
Registered
2023-04-04
Start date
2019-05-02
Completion date
2028-03-31
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Obesity, Infant

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 * 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/obesity to see if there are differences in child growth and adiposity .

Interventions

OTHERoverweight/obesity

the consequences of maternal pregestational overweight/obesity on infant´s growth and adiposity will be studied

Sponsors

Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
infant weightfrom birth to 2 years oldweight in kilograms
infant heightfrom birth to 2 years oldheight in centimeters
infant body mass index (BMI)from birth to 2 years oldweight and height will be combined to report BMI in kg/m\^2
infant upper arm circumferencefrom birth to 2 years oldupper arm circumference in centimeters
infant skinfold thicknessfrom birth to 2 years oldskinfold thickness in centimeters
infant blood leptin concentrationsix months oldblood leptin concentration (ng/ml)
infant blood cortisol concentrationsix months oldblood cortisol concentration (ug%)
infant saliva cortisol concentrationsix months oldsaliva cortisol (ug%)
infant blood insulin concentrationsix months oldblood insulin concentration (uU/ml)
infant insulin receptor gene expression in peripheral blood mononuclear cellssix months oldinsulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
infant leptin receptor gene expression in peripheral blood mononuclear cellssix months oldleptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
infant glucocorticoid receptor gene expression in peripheral blood mononuclear cellssix months oldglucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)
infant blood LEAP2 concentrationsix months oldblood LEAP2 concentration (pg/ml)
infant eating behavior assessed in a Taste acceptance testat 18 month odOutcome 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/v), 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. The 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. The 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.

Secondary

MeasureTime frameDescription
maternal blood leptin concentration15 days, three and six months postpartumblood leptin concentration (ng/ml)
maternal milk leptin concentration15 days, three and six months postpartummilk leptin concentration (ng/ml)
maternal blood insulin concentration15 days, three and six months postpartumblood insulin concentration (uU/ml)
maternal milk insulin concentration15 days, three and six months postpartummilk insulin concentration (uU/ml)
maternal blood cortisol concentration15 days, three and six months postpartumblood cortisol concentration (ug%)
maternal milk cortisol concentration15 days, three and six months postpartummilk cortisol concentration (ug%)
maternal insulin receptor gene expression in peripheral blood mononuclear cells15 days, three and six months postpartuminsulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
maternal leptin receptor gene expression in peripheral blood mononuclear cells15 days, three and six months postpartumleptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
maternal glucocorticoid receptor gene expression in peripheral blood mononuclear cells15 days, three and six months postpartumglucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)
maternal blood LEAP2 concentration15 days, three and six months postpartumblood LEAP2 concentration (pg/ml)
maternal milk LEAP2 concentration15 days, three and six months postpartummilk LEAP2 concentration (pg/ml)

Countries

Argentina

Contacts

Primary ContactMaria F Andreoli, PhD
mfandreoli@gmail.com54 221 4535901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026