Clinical trial NCT04937348: Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.
Official title: Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Diabetes
Diabetes Mellitus
Neonate
Nutritional Status
Keywords: gestational diabetes
adipokines
visfatin
omentin
nutritional status
neonate
breast milk
Lead sponsor: Wroclaw Medical University
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
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.

Brief 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Fat body mass [kg]
timeFrame: up to 6 months
measure: Total body water [l]
timeFrame: up to 6 months
measure: Anthropometrics: body weight [kg], length [cm], head circumference [cm].
timeFrame: up to 6 months
Secondary outcomes:
measure: Breast milk composition
timeFrame: up to 6 months
measure: Adipokines
timeFrame: up to 6 months
measure: Impact of maternal adipokines on infantile body fat mass.
timeFrame: up to 6 months
measure: Impact of maternal adipokines on breast milk composition.
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Department and Clinic of Neonatology, Jan Mikulicz-Radecki University Teaching Hospital, Wroclaw Medical University
state: Dolnoslaskie
Study officials:
References: