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Maternal Characteristics Associated With Child Growth and Adiposity

NCT ID: NCT05798676

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-02

Study Completion Date

2028-03-31

Brief Summary

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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 .

Detailed Description

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Conditions

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Obesity Obesity, Infant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

overweight/obesity

Intervention Type OTHER

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

Interventions

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overweight/obesity

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

Intervention Type OTHER

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria F Andreoli, BsC

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

La Plata, Buenos Aires, Argentina

Site Status RECRUITING

Countries

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Argentina

Central Contacts

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Maria F Andreoli, PhD

Role: CONTACT

Phone: 54 221 4535901

Email: [email protected]

Facility Contacts

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Maria F Andreoli, PhD

Role: primary

Ana Kruger, BsC

Role: backup

References

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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.

Reference Type DERIVED
PMID: 40450153 (View on PubMed)

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. Epub 2024 Sep 12.

Reference Type DERIVED
PMID: 39277116 (View on PubMed)

Other Identifiers

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L2022

Identifier Type: -

Identifier Source: org_study_id