An interventional study of Omega-3 Fatty Acids (EPA plus DHA) and Placebo in Gestational Diabetes Mellitus (GDM), sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud. Recruiting at 1 site in Spain. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Not applicable, Interventional, and Prevention
This project aims at identifying variations in breast milk neutrophils among lactating mothers with gestational diabetes or obesity (objective 1), and to describe how a dietary intervention with Omega-3 fatty acids affects these changes (objective 2). The occurrence of respiratory infections on the progeny will be analysed, as well as its development and the impact on gut microbiota and epigenetic changes (objective 3). The involvement of breast milk on the neonate's microbiota (sub-objective 1) and epigenetic variations (sub-objective 2) will be depicted. In addition, the direct engagement of milk neutrophils in the ability of the progeny to react against lung infections will be studied (sub-objective 3).
To attain these mother milk and blood samples will be obtained from three groups of lactating mothers: control, obesity or gestational diabetes, upon a dietary intervention with Omega-3 fatty acids. Neutrophil populations of maternal blood and milk samples will be studied by flow cytometry and in vitro assays. The microbiome and miRNA content of infant's saliva and tool samples will be characterized by 16s rRNA gene sequencing and PCR. The occurrence of respiratory infections and the development the infants participating in the study will be tracked during the first 2 years of life by telephone surveys.
To study the impact of the presented maternal variables on the progeny upon a respiratory inflammation on a systemic level, mouse models will be employed. The offspring of lactating dams with gestational diabetes or obesity will be subjected to an artificial acute lung infection. The progression of the lung disease will be studied by histology and the neutrophil profile in the organs of the litter by flow cytometry. The response to acute lung injury after fecal transplantation with infant's microbiota intro germ-free mice as well as of wild type pups breastfeed by neutropenic dams will complement the animal studies.
842 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's planned enrollment of 80 is below the median of 110 across 549 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud is the lead sponsor of 71 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Dietary Supplement: Omega-3 Fatty Acids (EPA plus DHA)
Dietary Supplement: Placebo
Dietary supplementation with Omega-3 Fatty Acids to study the effect on the immune system of breast milk
Inert dietary supplement, without activity in the activation of the immune system of breast milk
Characterization of milk neutrophils from three groups of lactating mothers: control or gestational diabetes.
Time frame: From enrollment to end of treatment at 3 months
Characterization of microbiota and miRNA content of breast milk
Time frame: From enrollment to end of treatment at 3 months
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud