Impact of Maternal Metabolic Abnormalities in Pregnancy on Human Milk and Subsequent Infant Metabolic Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Infant growth
研究概览
简要总结
Childhood obesity is on the rise and is a major risk factor for type 2 diabetes later in life. Recent evidence indicates that abnormalities that increase risk for diabetes may be initiated early in infancy. Since the offspring of women with diabetes have an increased long-term risk for obesity and type 2 diabetes, the impact of maternal metabolic abnormalities on early nutrition and infant metabolic trajectories is of considerable interest. The purpose of the study is to investigate the impact of maternal nutrition and metabolic abnormalities in pregnancy on human milk and subsequently on infant health over the first year of life.
详细描述
The current investigation is a prospective study conducted within ongoing cohort studies of women and their offspring. Pregnant women attending outpatient obstetrics clinics in Toronto, Canada are recruited. The overall study protocol includes four study visits between the second half of pregnancy and the first year of infant's life and interim phone call interviews:
- Pregnant women undergo an oral glucose tolerance test at an expected average of 30 weeks of gestation and complete medical and lifestyle questionnaires including food frequency questionnaires.
- Infant birth anthropometry measurements and human milk samples are collected at an expected average of 3 days postpartum. The timing of onset of lactogenesis II is asked at 3d, 5d, 7d postpartum or until the event occurrence up to day 7.
- At 3 months postpartum, follow-up assessments including infant anthropometry, medical and lifestyle questionnaires and human milk sample collection are completed.
- Interim telephone interviews are conducted at 6 weeks and 5, 7, 9 months postpartum to characterize infant feeding and supplementation behaviors.
- At 12 months postpartum, infant anthropometric assessments are conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •singleton or twin pregnancy
- •aged 20 years or older at the time of recruitment
- •intention to breastfeed
排除标准
- •pre-existing diabetes
结局指标
主要结局
Infant growth
时间窗: Growth from birth to anthrometry at 12mo
次要结局
- Onset of lactogenesis II(At 3d, 5d, 7d postpartum until the event occurrence of milk-coming-in up to day 7.)
- Human milk composition(At 3d and at 3mo postpartum)
- Gestational metabolic abnormalities(An expected average of 30 weeks of gestation)
- Gestational diabetes(An expected average of 30 weeks of gestation)
- Getational hyperglycemia and insulinemia (insulin resistance/sensitivity)(An expected average of 30 weeks of gestation)
研究者
Anthony Hanley
Associate Professor
University of Toronto