Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.

Diabetes Mellitus Clinical Trial

Official title: Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Neonate
• Nutritional Status

• NCT number: NCT04937348
• Study type: Observational
• Source: Wroclaw Medical University
• Status: Completed
• Start date: December 13, 2019
• Completion date: March 17, 2021