Maternal Characteristics Associated With Child Growth and Adiposity

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05798676
• Other study ID #: L2022
• Status: Recruiting
• Start date: May 2, 2019
• Est. completion date: March 2026

Study information

• Verified date: June 2023
• Source: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
• Contact: Maria F Andreoli, PhD
• Phone: 54 221 4535901
• Email: mfandreoli[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: March 2026
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Obesity, Infant
• Pediatric Obesity

Intervention

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

Locations

Country	Name	City	State
Argentina	Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri	La Plata	Buenos Aires

Sponsors (1)

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

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infant weight	weight in kilograms	from birth to 2 years old
Primary	infant height	height in centimeters	from birth to 2 years old
Primary	infant body mass index (BMI)	weight and height will be combined to report BMI in kg/m^2	from birth to 2 years old
Primary	infant upper arm circumference	upper arm circumference in centimeters	from birth to 2 years old
Primary	infant skinfold thickness	skinfold thickness in centimeters	from birth to 2 years old
Primary	infant blood leptin concentration	blood leptin concentration (ng/ml)	six months old
Primary	infant blood cortisol concentration	blood cortisol concentration (ug%)	six months old
Primary	infant saliva cortisol concentration	saliva cortisol (ug%)	six months old
Primary	infant blood insulin concentration	blood insulin concentration (uU/ml)	six months old
Primary	infant insulin receptor gene expression in peripheral blood mononuclear cells	insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)	six months old
Primary	infant leptin receptor gene expression in peripheral blood mononuclear cells	leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)	six months old
Primary	infant glucocorticoid receptor gene expression in peripheral blood mononuclear cells	glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)	six months old
Primary	infant blood LEAP2 concentration	blood LEAP2 concentration (pg/ml)	six months old
Secondary	maternal blood leptin concentration	blood leptin concentration (ng/ml)	15 days, three and six months postpartum
Secondary	maternal milk leptin concentration	milk leptin concentration (ng/ml)	15 days, three and six months postpartum
Secondary	maternal blood insulin concentration	blood insulin concentration (uU/ml)	15 days, three and six months postpartum
Secondary	maternal milk insulin concentration	milk insulin concentration (uU/ml)	15 days, three and six months postpartum
Secondary	maternal blood cortisol concentration	blood cortisol concentration (ug%)	15 days, three and six months postpartum
Secondary	maternal milk cortisol concentration	milk cortisol concentration (ug%)	15 days, three and six months postpartum
Secondary	maternal insulin receptor gene expression in peripheral blood mononuclear cells	insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)	15 days, three and six months postpartum
Secondary	maternal leptin receptor gene expression in peripheral blood mononuclear cells	leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)	15 days, three and six months postpartum
Secondary	maternal glucocorticoid receptor gene expression in peripheral blood mononuclear cells	glucocorticoid receptor gene expression in peripheral blood mononuclear cells (relative expression)	15 days, three and six months postpartum
Secondary	maternal blood LEAP2 concentration	blood LEAP2 concentration (pg/ml)	15 days, three and six months postpartum
Secondary	maternal milk LEAP2 concentration	milk LEAP2 concentration (pg/ml)	15 days, three and six months postpartum