Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.
Condition: Gestational Diabetes; Diabetes Mellitus; Neonate; Nutritional Status
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Observational

Summary: 
      Diabetes mellitus is one of the most common metabolic disorders complicating the course of
      pregnancy, which concerns pre-pregnancy diabetes (PGDM) - most often type 1 or type 2; and
      gestational diabetes (GDM) - treated with diet (G1) or insulin (G2). Currently, in the
      pathogenesis of diabetes and the regulation of glucose metabolism, the role of tissue
      hormones, including adipokines, e.g., omentin-1, visfatin, have been considered. Adipokines
      might also affect the development of the fetus - mainly fetal adipose tissue gain. Their
      concentrations and activity depend on the maternal visceral fat content and concomitant
      metabolic disorders. It is known that adipokines are excreted in human milk during the
      lactation period.

      The aim of the study was to assess the impact of diabetes during pregnancy, requiring
      treatment with diet or insulin, on the nutritional status of the newborn.
    

Detailed description: 
      The detailed aim of the study was to analyze the relationship between the concentration of
      selected adipokines, visfatin and omentin-1 in the mother, and the nutritional status of the
      newborn (expressed as body composition and anthropometric measurements), as well as the
      composition of breast milk, and clinical data on the course of pregnancy, childbirth,
      puerperium (interview from mother) and the postnatal stay of the child in the hospital.

      Primary protocol:

      The research was going to be conducted twice, that is:

        1. in the period of postnatal hospitalization of the newborn, before discharge from the
           hospital (up to 7 days of age) in the Neonatology Clinic,

        2. in the 4th - 6th week of the child's life, after visiting the Neonatology Outpatient
           Clinic.

      Apart from the clinical examination, anthropometric measurements and body composition
      measurements, the results of laboratory tests performed on a child during hospitalization up
      to the 7th day of life and at the 4-6 week of life were collected. The interview
      questionnaire was carried out twice with the child's mother. From the mother, at the same
      time, milk (colostrum and mature) and blood was collected for laboratory tests.

      Further changes in the protocol (accepted by Bioethical Comitte):

        1. Extending the project with further study visits, i.e. 6-12 weeks and if the mother
           wishes to continue participation, 13 weeks - 6 months after delivery, in the case of
           sustained lactation and further breastfeeding, before introducing solid food into the
           child's diet.

           Substantiation: Due to the COVID-19 pandemic, the second project visit was abandoned.
           Based on telephone calls, the patients were still interested in participating, the more
           so as they had not completed the prescribed postpartum check-ups, their scheduled visits
           to specialists were canceled, and the infant vaccinations had been postponed. Patients
           also reported the need for lactation advice. Additional dates (6-12 weeks after
           childbirth and 13 weeks to 6 months after childbirth) would enable inviting mothers and
           their babies, providing medical or lactation advice according to their needs, as well as
           continuing the project among patients and their children who had been included in the
           study so far.

        2. Cooperation with Biobank of Wrocław Medical University was established.

      Substantiation: Possibility of collecting and storing biological material for further
      research in safe and controlled conditions.
    

Intervention name(s): Acquisition and analysis of milk samples; Collection, preparation and analysis of mother's blood samples.; Body composition assessment; Anthropometric measurements
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Other
Intervention description(s): In order to ensure reproducible results, breast milk samples were collected using a breast pump. Samples were taken in the morning, after the newborn was breastfed. The entire breast was emptied. In order to ensure the stability of the microbiological and nutritional composition, the milk samples were cooled immediately after collection, and then divided into test tubes and frozen (-80 C) until the laboratory tests were made.
The concentrations of macronutrients (protein, fat, carbohydrate) in breast milk were determined using a Human Milk Analyzer (HMA; Miris, Uppsala). Tissue hormones, e.g. adipokines: visfatin, omentin-1 were determined by ELISA method using commercial reagent kits.; Blood samples were collected from the mothers (fasting if possible) on the day the milk samples were taken. After collection, fasting glucose and insulin, as well as glycated hemoglobin were marked, and the other samples were centrifuged and frozen until analyzed (-80 C). Determination of adipokines was performed by ELISA method, using commercial reagent kits.; The body composition of newborns was determined by a non-invasive electrical bioimpedance method using the body composition analyzer.; Based on the mother's medical records, maternal height and pregnancy weight changes were recorded. On the day the biological material is collected, the mother was weighed.
From the baby's documentation, measurements of the length, head circumference and body weight taken after delivery and during the hospitalization were recorded. These measurements were repeated on the days of the body composition analysis.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study group included mothers with diagnosed diabetes and their newborns. Women with
        gestational diabetes, both treated with diet and treated with insulin - each group was
        supposed to include at least 20 patients. Additionally, if possible, women diagnosed with
        type 1 and type 2 pre-pregnancy diabetes or insulin resistance might have been included in
        the study. The control group consisted of 20 healthy women and their newborns.
      
Biospecimen description: 
      serum, breast milk
    
Keywords: gestational diabetes; adipokines; visfatin; omentin; nutritional status; neonate; breast milk