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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| overweight/obesity | Other | the consequences of maternal pregestational overweight/obesity on infant´s growth and adiposity will be studied |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| maternal blood leptin concentration | blood leptin concentration (ng/ml) | 15 days, three and six months postpartum |
| maternal milk leptin concentration | milk leptin concentration (ng/ml) |
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Inclusion Criteria:
Exclusion Criteria:
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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 MarÃa Ludovica", La Plata, Argentina.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria F Andreoli, PhD | Contact | 54 221 4535901 | 1767 | mfandreoli@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Maria F Andreoli, BsC | Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri | Recruiting | La Plata | Buenos Aires | 1900 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40450153 | Derived | 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. | |
| 39277116 |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D050154 | Adiposity |
| ID | Term |
|---|---|
| D050218 | Body Fat Distribution |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
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blood and milk
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 |
| 15 days, three and six months postpartum |
| maternal blood insulin concentration | blood insulin concentration (uU/ml) | 15 days, three and six months postpartum |
| maternal milk insulin concentration | milk insulin concentration (uU/ml) | 15 days, three and six months postpartum |
| maternal blood cortisol concentration | blood cortisol concentration (ug%) | 15 days, three and six months postpartum |
| maternal milk cortisol concentration | milk cortisol concentration (ug%) | 15 days, three and six months postpartum |
| 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 |
| 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 |
| 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 |
| maternal blood LEAP2 concentration | blood LEAP2 concentration (pg/ml) | 15 days, three and six months postpartum |
| maternal milk LEAP2 concentration | milk LEAP2 concentration (pg/ml) | 15 days, three and six months postpartum |
| 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D001823 | Body Composition |
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D010829 | Physiological Phenomena |