Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.
NCT ID: NCT04937348
Last Updated: 2021-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
70 participants
OBSERVATIONAL
2019-12-13
2021-03-17
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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GDM G1
Mothers diagnosed with gestational diabetes mellitus, treated with diet; and their newborns
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.
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.
GDM G2
Mothers diagnosed with gestational diabetes mellitus, treated with insulin; and their newborns
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.
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.
non-GDM / control group
Healthy, non-diabetic mothers, without disturbances in glucose metabolism; and their newborns.
Control group.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
45 Years
FEMALE
Yes
Sponsors
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Wroclaw Medical University
OTHER
Responsible Party
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Locations
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Department and Clinic of Neonatology, Jan Mikulicz-Radecki University Teaching Hospital, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland
Countries
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Other Identifiers
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STM.A300.20.143
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
773/2019
Identifier Type: -
Identifier Source: org_study_id
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