Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.
2 other identifiers
observational
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2021
CompletedFirst Submitted
Initial submission to the registry
June 11, 2021
CompletedFirst Posted
Study publicly available on registry
June 24, 2021
CompletedJune 24, 2021
May 1, 2021
1.2 years
June 11, 2021
June 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (4)
Breast milk composition
up to 6 months
Adipokines
up to 6 months
Impact of maternal adipokines on infantile body fat mass.
up to 6 months
Impact of maternal adipokines on breast milk composition.
up to 6 months
Study Arms (3)
GDM G1
Mothers diagnosed with gestational diabetes mellitus, treated with diet; and their newborns
GDM G2
Mothers diagnosed with gestational diabetes mellitus, treated with insulin; and their newborns
non-GDM / control group
Healthy, non-diabetic mothers, without disturbances in glucose metabolism; and their newborns. Control group.
Interventions
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.
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.
The body composition of newborns was determined by a non-invasive electrical bioimpedance method using the body composition analyzer.
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
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.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department and Clinic of Neonatology, Jan Mikulicz-Radecki University Teaching Hospital, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
Biospecimen
serum, breast milk
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2021
First Posted
June 24, 2021
Study Start
December 13, 2019
Primary Completion
February 5, 2021
Study Completion
March 17, 2021
Last Updated
June 24, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share