NCT Number: NCT05798676
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 .
Interested in participating?
Request Info18 year–40 year
Female
Observational
La Plata, Buenos Aires, 1900, Argentina
Location status: Recruiting
Ana Kruger, BsC
CONTACT
54 221 4535901 ext. 1767
Maria F Andreoli, PhD
CONTACT
54 221 4535901 ext. 1767
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
the consequences of maternal pregestational overweight/obesity on infant´s growth and adiposity will be studied
Time frame: from birth to 2 years old
weight in kilograms
Time frame: from birth to 2 years old
height in centimeters
Time frame: from birth to 2 years old
weight and height will be combined to report BMI in kg/m^2
Time frame: from birth to 2 years old
upper arm circumference in centimeters
Time frame: from birth to 2 years old
skinfold thickness in centimeters
Time frame: six months old
blood leptin concentration (ng/ml)
Time frame: six months old
blood cortisol concentration (ug%)
Time frame: six months old
saliva cortisol (ug%)
Time frame: six months old
blood insulin concentration (uU/ml)
Time frame: six months old
insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Time frame: six months old
leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Time frame: six months old
glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)
Time frame: six months old
blood LEAP2 concentration (pg/ml)
Time frame: at 18 month od
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/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.
Time frame: 15 days, three and six months postpartum
blood leptin concentration (ng/ml)
Time frame: 15 days, three and six months postpartum
milk leptin concentration (ng/ml)
Time frame: 15 days, three and six months postpartum
blood insulin concentration (uU/ml)
Time frame: 15 days, three and six months postpartum
milk insulin concentration (uU/ml)
Time frame: 15 days, three and six months postpartum
blood cortisol concentration (ug%)
Time frame: 15 days, three and six months postpartum
milk cortisol concentration (ug%)
Time frame: 15 days, three and six months postpartum
insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Time frame: 15 days, three and six months postpartum
leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Time frame: 15 days, three and six months postpartum
glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)
Time frame: 15 days, three and six months postpartum
blood LEAP2 concentration (pg/ml)
Time frame: 15 days, three and six months postpartum
milk LEAP2 concentration (pg/ml)
Contact information is provided by the study sponsor or research team.
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Other
Maternal Characteristics Associated With Child Growth and Adiposity. Search for Nutrigenomic Biomarkers in Peripheral Blood
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04991402
Body Weight, Female Urogenital Diseases and Pregnancy Complications
Cape Town, South Africa
View Trial DetailsNCT06575738
Adolescent Obesity, Anti-obesity Agents
Aurora, Colorado, United States
View Trial DetailsNCT05028205
Body Weight, Childhood Obesity
Knoxville, Tennessee, United States
View Trial DetailsNCT06903923
Body Weight, Bone Density
Charlottesville, Virginia, United States
View Trial Details