NCT03524469已完成不适用
Studying Infant Nutrition and Glycemia (SING)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- mean infant postprandial C peptide to creatinine ratio
研究概览
简要总结
The purpose of this study is to learn about how breast milk from mothers with insulin-resistance may be different. Investigators are specifically studying insulin concentrations in breast milk. Investigators are also studying how insulin in breast milk might affect a baby's intestines and pancreas.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mothers ≥ 19 years of age
- •Mothers intending to Exclusively Breastfeed for at least 5months
- •Mothers comfortable with feeding their infants expressed breast milk from a bottle at 2-weeks postpartum
- •Trial of labor (no scheduled C-sections)
- •Singleton birth
- •Healthy Infants
- •"Normal Weight" will be defined as pre-pregnant BMI between 18.5-23.9 kg/m2 and passing the 28 week oral glucose tolerance test.
- •"Insulin Resistance" will be defined as meeting any of the following:
- •pre-pregnant BMI ≥ 28 and failed the 28 week oral glucose screening test
- •pre-pregnant BMI ≥ 28 and diagnosis of either A1 ("diet controlled") or A2 ("insulin-requiring") gestational diabetes during pregnancy, but insulin therapy discontinued after birth.
- •pre-pregnant BMI ≥ 28 and diagnosed with type 2 diabetes during pregnancy
- •pre-pregnant BMI ≥ 30, and unmediated.
排除标准
- •Scheduled C-sections or emergency C-sections with no labor (natural or induced)
- •Maternal insulin therapy after birth
- •Significant maternal health concern including type 1 diabetes, renal, kidney, thyroid, or cardiovascular disease, pre-eclampsia, or other disease.
- •Delivery before 37 weeks
- •Infant birth weight <2500g
- •Infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns
- •Infant supplementation with infant formula (glucose gel or donor milk is acceptable)
结局指标
主要结局
mean infant postprandial C peptide to creatinine ratio
时间窗: 2 weeks
Postprandial urine (60-90 minute) will be tested for C peptide and creatinine and the ratio will be calculated.
次要结局
- mean infant insulinogenic index(5 months)
研究者
Bridget Young
Research Assistant Professor
University of Rochester
研究点 (1)
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