Maternal Characteristics Associated With Child Growth and Adiposity

December 19, 2025 updated by: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

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

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 .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1900
        • Recruiting
        • Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
mothers with pre-pregnancy normal weight and their infants
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
mothers with pre-pregnancy overweight or obesity according to World Health Organization will provide blood and milk samples
Other: overweight/obesity
the consequences of maternal pregestational overweight/obesity on infant´s growth and adiposity will be studied

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
infant weight
Time Frame: from birth to 2 years old
weight in kilograms
from birth to 2 years old
infant height
Time Frame: from birth to 2 years old
height in centimeters
from birth to 2 years old
infant body mass index (BMI)
Time Frame: from birth to 2 years old
weight and height will be combined to report BMI in kg/m^2
from birth to 2 years old
infant upper arm circumference
Time Frame: from birth to 2 years old
upper arm circumference in centimeters
from birth to 2 years old
infant skinfold thickness
Time Frame: from birth to 2 years old
skinfold thickness in centimeters
from birth to 2 years old
infant blood leptin concentration
Time Frame: six months old
blood leptin concentration (ng/ml)
six months old
infant blood cortisol concentration
Time Frame: six months old
blood cortisol concentration (ug%)
six months old
infant saliva cortisol concentration
Time Frame: six months old
saliva cortisol (ug%)
six months old
infant blood insulin concentration
Time Frame: six months old
blood insulin concentration (uU/ml)
six months old
infant insulin receptor gene expression in peripheral blood mononuclear cells
Time Frame: six months old
insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
six months old
infant leptin receptor gene expression in peripheral blood mononuclear cells
Time Frame: six months old
leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
six months old
infant glucocorticoid receptor gene expression in peripheral blood mononuclear cells
Time Frame: six months old
glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)
six months old
infant blood LEAP2 concentration
Time Frame: six months old
blood LEAP2 concentration (pg/ml)
six months old
infant eating behavior assessed in a Taste acceptance test
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.
at 18 month od

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
maternal blood leptin concentration
Time Frame: 15 days, three and six months postpartum
blood leptin concentration (ng/ml)
15 days, three and six months postpartum
maternal milk leptin concentration
Time Frame: 15 days, three and six months postpartum
milk leptin concentration (ng/ml)
15 days, three and six months postpartum
maternal blood insulin concentration
Time Frame: 15 days, three and six months postpartum
blood insulin concentration (uU/ml)
15 days, three and six months postpartum
maternal milk insulin concentration
Time Frame: 15 days, three and six months postpartum
milk insulin concentration (uU/ml)
15 days, three and six months postpartum
maternal blood cortisol concentration
Time Frame: 15 days, three and six months postpartum
blood cortisol concentration (ug%)
15 days, three and six months postpartum
maternal milk cortisol concentration
Time Frame: 15 days, three and six months postpartum
milk cortisol concentration (ug%)
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
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
Time Frame: 15 days, three and six months postpartum
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
Time Frame: 15 days, three and six months postpartum
glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)
15 days, three and six months postpartum
maternal blood LEAP2 concentration
Time Frame: 15 days, three and six months postpartum
blood LEAP2 concentration (pg/ml)
15 days, three and six months postpartum
maternal milk LEAP2 concentration
Time Frame: 15 days, three and six months postpartum
milk LEAP2 concentration (pg/ml)
15 days, three and six months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria F Andreoli, BsC, Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • L2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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