Visfatin and Omentin-1 - Markers of Nutritional Status of Newborns Born to Diabetic Mothers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Fat body mass [kg]
研究概览
简要总结
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.
详细描述
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:
- in the period of postnatal hospitalization of the newborn, before discharge from the hospital (up to 7 days of age) in the Neonatology Clinic,
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Fat body mass [kg]
时间窗: up to 6 months
Changes in infantile fat body mass between 2 timepoints (the first week of life and the 2nd visit).
Total body water [l]
时间窗: up to 6 months
Changes in infantile total body water between 2 timepoints (the first week of life and the 2nd visit).
Anthropometrics: body weight [kg], length [cm], head circumference [cm].
时间窗: up to 6 months
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).
次要结局
- 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)