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

NCT04937348 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2021-06-24

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Acquisition and analysis of milk samples

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.

DIAGNOSTIC_TEST

Collection, preparation and analysis of mother's blood samples.

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.

DIAGNOSTIC_TEST

Body composition assessment

The body composition of newborns was determined by a non-invasive electrical bioimpedance method using the body composition analyzer.

OTHER

Anthropometric measurements

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.

Sponsors & Collaborators

  • Wroclaw Medical University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-13
Primary Completion
2021-02-05
Completion
2021-03-17

Countries

  • Poland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04937348 on ClinicalTrials.gov