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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04937348
• Other study ID #: 773/2019
• Secondary ID: STM.A300.20.143
• Status: Completed
• Start date: December 13, 2019
• Est. completion date: March 17, 2021

Study information

• Verified date: May 2021
• Source: Wroclaw Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 17, 2021
• Est. primary completion date: February 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• mother's age 18 - 45 years;

• delivery at term (= 37 + 0/7 weeks of pregnancy) or close to the delivery date (from 35 + 0/7 to 36 + 6/7 weeks of pregnancy), both by vaginal delivery and by caesarean section;

• single pregnancy;

• good condition of the child after birth, rated > 7 points on the Apgar score after the 1 st minute of life;

• feeding the baby only naturally (with breast or expressed breast milk) or mainly naturally;

• mother's informed and voluntary consent to participate in the study;

• mother's informed and voluntary consent to the participation of her child in the study.

Exclusion Criteria:

• mother's lack of consent to participate in the study;

• mother's lack of consent to the participation of her child in the study;

• mother's age <18 years and > 45 years;

• preterm labor <35 + 0/7 weeks of pregnancy;

• multiple pregnancy;

• the child's condition at birth is moderate or severe, rated at = 7 points on the Apgar score after the 1st minute of life;

• feeding a child exclusively or mainly with an infant formula;

• severe birth defects of a newborn,

• any clinical condition of the mother and / or the newborn that may affect the nutritional status of the newborn (IUGR, lack of medical care during pregnancy, addiction of the mother to alcohol or other psychoactive substances, nicotinism in pregnancy, uncontrolled asthma in the mother, metabolic diseases in the mother or newborn).

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Poland	Department and Clinic of Neonatology, Jan Mikulicz-Radecki University Teaching Hospital, Wroclaw Medical University	Wroclaw	Dolnoslaskie

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fat body mass [kg]	Changes in infantile fat body mass between 2 timepoints (the first week of life and the 2nd visit).	up to 6 months
Primary	Total body water [l]	Changes in infantile total body water between 2 timepoints (the first week of life and the 2nd visit).	up to 6 months
Primary	Anthropometrics: body weight [kg], length [cm], head circumference [cm].	Changes in infantile anthropometrics between 2 timepoints (the first week of life and the 2nd visit). On the basis of weight and length, BMI (kg/m2) and Ponderal Index will be calculated (kg/m3).	up to 6 months
Secondary	Breast milk composition	Influence of diabetes mellitus in the course of pregnancy on the breast milk content of: protein [g/dl], carbohydrates [g/dl], fat [g/dl], energy [kcal/dl].	up to 6 months
Secondary	Adipokines	Differences in omentin-1 and visfatin concentrations in serum and breastmilk samples between the study groups.	up to 6 months
Secondary	Impact of maternal adipokines on infantile body fat mass.	Correlation of adipokines' concentrations with infantile fat mass will be analysed.	up to 6 months
Secondary	Impact of maternal adipokines on breast milk composition.	Correlation of adipokines' concentrations with breast milk content of: protein [g/dl], carbohydrates [g/dl], fat [g/dl], energy [kcal/dl] will be analysed.	up to 6 months