Health TrialsbyHealthPanel

Maternal Characteristics Associated With Child Growth and Adiposity

ConditionsObesityObesity, Infant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorInstituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

About this trial

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 .

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Diabetes (Type I or II or gestational)

Multiple pregnancy

Hypertensive disorders during pregnancy

Delivery of pre-term infant (<37 weeks).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • overweight/obesity

    Other intervention

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

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: mothers with pre-pregnancy normal weight and their infants0 interventions
Group B: mothers with pre-pregnancy overweight or obesity and their infants1 intervention

Trial outcomes

Primary outcomes

1

infant weight

weight in kilograms

Time frame
from birth to 2 years old
2

infant height

height in centimeters

Time frame
from birth to 2 years old
3

infant body mass index (BMI)

weight and height will be combined to report BMI in kg/m\^2

Time frame
from birth to 2 years old
4

infant upper arm circumference

upper arm circumference in centimeters

Time frame
from birth to 2 years old

Secondary outcomes

1

maternal blood leptin concentration

blood leptin concentration (ng/ml)

Time frame
15 days, three and six months postpartum
2

maternal milk leptin concentration

milk leptin concentration (ng/ml)

Time frame
15 days, three and six months postpartum
3

maternal blood insulin concentration

blood insulin concentration (uU/ml)

Time frame
15 days, three and six months postpartum
4

maternal milk insulin concentration

milk insulin concentration (uU/ml)

Time frame
15 days, three and six months postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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