Maternal Characteristics Associated With Child Growth and Adiposity

NCT05798676 | Recruiting

• 1 other identifier: L2022
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Obesity; Obesity, Infant

Outcome Measures

Primary Outcomes (14)

• 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

• infant blood LEAP2 concentration

  blood LEAP2 concentration (pg/ml)

  six months old

• infant eating behavior assessed in a Taste acceptance test

  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 Outcomes (11)

• maternal blood leptin concentration

  15 days, three and six months postpartum

• maternal milk leptin concentration

  15 days, three and six months postpartum

• maternal blood insulin concentration

  15 days, three and six months postpartum

• maternal milk insulin concentration

  15 days, three and six months postpartum

• maternal blood cortisol concentration

  15 days, three and six months postpartum

Study Arms (2)

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

Interventions

overweight/obesity OTHER

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

mothers with pre-pregnancy overweight or obesity and their infants

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• Diabetes (Type I or II or gestational)
• Multiple pregnancy
• Hypertensive disorders during pregnancy
• Delivery of pre-term infant (\<37 weeks).

Sponsors & Collaborators

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

Study Sites (1)

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

La Plata, Buenos Aires, 1900, Argentina

RECRUITING

Related Publications (2)

• 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.

  PMID: 40450153 DERIVED

• 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.

  PMID: 39277116 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood and milk

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Interventions

Adiposity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Study Officials

• Maria F Andreoli, BsC

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria F Andreoli, PhD

CONTACT

54 221 4535901; mfandreoli@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: April 4, 2023
• Study Start: May 2, 2019
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

AR (1)