Maternal Characteristics Associated With Child Growth and Adiposity

Study Overview
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Brief Summary
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The goal of this observational study is to investigate the concentrations of leptin, insulin 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 .

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

Conditions
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Obesity, Obesity, Infant

Intervention / Treatment
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* Other: overweight/obesity


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mothers with pre-pregnancy normal weight and their infants<br>mothers with pre-pregnancy normal weight according to World Health Organization will provide blood and milk samples | |
| mothers with pre-pregnancy overweight or obesity and their infants<br>mothers with pre-pregnancy overweight or obesity according to World Health Organization will provide blood and milk samples | Other: overweight/obesity<br>* the consequences of maternal pregestational overweight/obesity on infant´s growth and adiposity will be studied<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infant weight | weight in kilograms | from birth to 2 years old | 
| infant height | height in centimeters | from birth to 2 years old | 
| infant body mass index (BMI) | weight and height will be combined to report BMI in kg/m^2 | from birth to 2 years old | 
| infant upper arm circumference | upper arm circumference in centimeters | from birth to 2 years old | 
| infant skinfold thickness | skinfold thickness in centimeters | from birth to 2 years old | 
| infant blood leptin concentration | blood leptin concentration (ng/ml) | six months old | 
| infant blood cortisol concentration | blood cortisol concentration (ug%) | six months old | 
| infant saliva cortisol concentration | saliva cortisol (ug%) | six months old | 
| infant blood insulin concentration | blood insulin concentration (uU/ml) | six months old | 
| infant insulin receptor gene expression in peripheral blood mononuclear cells | insulin receptor gene expression in peripheral blood mononuclear cells (relative expression) | six months old | 
| infant leptin receptor gene expression in peripheral blood mononuclear cells | leptin receptor gene expression in peripheral blood mononuclear cells (relative expression) | six months old | 
| infant glucocorticoid receptor gene expression in peripheral blood mononuclear cells | glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression) | six months old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal blood leptin concentration | blood leptin concentration (ng/ml) | 15 days, three and six months postpartum | 
| maternal milk leptin concentration | milk leptin concentration (ng/ml) | 15 days, three and six months postpartum | 
| maternal blood insulin concentration | blood insulin concentration (uU/ml) | 15 days, three and six months postpartum | 
| maternal milk insulin concentration | milk insulin concentration (uU/ml) | 15 days, three and six months postpartum | 
| maternal blood cortisol concentration | blood cortisol concentration (ug%) | 15 days, three and six months postpartum | 
| maternal milk cortisol concentration | milk cortisol concentration (ug%) | 15 days, three and six months postpartum | 
| maternal insulin receptor gene expression in peripheral blood mononuclear cells | insulin receptor gene expression in peripheral blood mononuclear cells (relative expression) | 15 days, three and six months postpartum | 
| maternal leptin receptor gene expression in peripheral blood mononuclear cells | leptin receptor gene expression in peripheral blood mononuclear cells (relative expression) | 15 days, three and six months postpartum | 
| maternal glucocorticoid receptor gene expression in peripheral blood mononuclear cells | glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression) | 15 days, three and six months postpartum |