Maternal Characteristics Associated With Child Growth and Adiposity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: overweight/obesity.
- Who it may be relevant to
- Registry conditions: Obesity, Obesity, Infant. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Maternal Characteristics Associated With Child Growth and Adiposity. Search for Nutrigenomic Biomarkers in Peripheral Blood
Overview
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
- Other overweight/obesity
the consequences of maternal pregestational overweight/obesity on infant´s growth and adiposity will be studied
Primary outcome measures
- infant weight [Time frame: from birth to 2 years old]
- infant height [Time frame: from birth to 2 years old]
- infant body mass index (BMI) [Time frame: from birth to 2 years old]
- infant upper arm circumference [Time frame: from birth to 2 years old]
- infant skinfold thickness [Time frame: from birth to 2 years old]
- infant blood leptin concentration [Time frame: six months old]
- infant blood cortisol concentration [Time frame: six months old]
- infant saliva cortisol concentration [Time frame: six months old]
- infant blood insulin concentration [Time frame: six months old]
- infant insulin receptor gene expression in peripheral blood mononuclear cells [Time frame: six months old]
Secondary outcome measures (11)
- maternal blood leptin concentration [Time frame: 15 days, three and six months postpartum]
- maternal milk leptin concentration [Time frame: 15 days, three and six months postpartum]
- maternal blood insulin concentration [Time frame: 15 days, three and six months postpartum]
- maternal milk insulin concentration [Time frame: 15 days, three and six months postpartum]
- maternal blood cortisol concentration [Time frame: 15 days, three and six months postpartum]
- maternal milk cortisol concentration [Time frame: 15 days, three and six months postpartum]
- maternal insulin receptor gene expression in peripheral blood mononuclear cells [Time frame: 15 days, three and six months postpartum]
- maternal leptin receptor gene expression in peripheral blood mononuclear cells [Time frame: 15 days, three and six months postpartum]
- maternal glucocorticoid receptor gene expression in peripheral blood mononuclear cells [Time frame: 15 days, three and six months postpartum]
- maternal blood LEAP2 concentration [Time frame: 15 days, three and six months postpartum]
- maternal milk LEAP2 concentration [Time frame: 15 days, three and six months postpartum]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Argentina · 1 center
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri — La Plata
Publications
- Kruger AL, Malpeli A, Sala M, Casado C, Mendez I, Fotia L, Tournier A, Fasano MV, Andreoli MF. Human milk cortisol is inversely associated with infant BMI and mediates the association between maternal plasma and infant salivary cortisol concentrations. Int J Obes (Lond). 2025 Aug;49(8):1632-1641. doi: 10.1038/s41366-025-01815-4. Epub 2025 May 31. PMID 40450153
- Kruger AL, Malpeli A, Sala M, Casado C, Mendez I, Fotia L, Lopez M, Tournier A, Castrogiovanni D, Heredia F, Llovera R, Schioth HB, Perello M, Andreoli MF. The Concentration of Liver-Expressed Antimicrobial Peptide 2 in Human Milk and Infant Plasma Is Positively Associated with Adiposity and Body Weight in the First Year of Life. J Nutr. 2024 Nov;154(11):3388-3399. doi: 10.1016/j.tjnut.2024.09.008 PMID 39277116
Identifiers
NCT: NCT05798676 · L2022