NCT02285764已完成不适用
NIGO Health- Nutritional Intervention During Gestation and Offspring Health
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 6
- 主要终点
- Maternal Oral Glucose Tolerance Test (OGTT)
研究概览
简要总结
The purpose of this study is to investigate the potential effects of a modified carbohydrate nutritional product for obese pregnant women to reduce maternal glycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Voluntarily signed and dated an ICF, approved by an IEC/IRB and provided applicable privacy authorization prior to any participation in the study.
- •Obese (BMI ≥ 30) as determined by pre-pregnancy BMI.
- •≥18 years of age.
- •≥15+0 but ≤16+6 weeks gestation with a singleton pregnancy.
- •Willing to follow supplementation protocol and follow appropriate nutritional guidance and refrain from consuming other caloric nutritional supplements that are not approved by the study staff, if applicable.
- •Willing to provide body composition measures on infant at birth.
- •Willing to consider additional measures if follow-up studies are conducted.
排除标准
- •Adverse maternal and/or fetal medical history which is expected to alter blood glucose regulations.
- •Previously diagnosed diabetes, previous gestational diabetes, systemic lupus erythematodes, anti-phospholipid syndrome, known renal disease, treated hypertension, uncontrolled hypothyroidism and/or cancer.
- •Taking medications that can impact blood glucose.
- •Previous bariatric surgery.
- •Lactose intolerant and/or has milk protein allergy or requires a special diet regime.
- •Participating in another clinical trial that would impact participation in this study.
研究组 & 干预措施
Nutritional Supplement
Experimental
One 237 ml oral supplement consumed two times a day; Not commercially available.
干预措施: Nutritional Supplement (Other)
Standard of Care
Other
As determined by the study site
干预措施: Standard of Care (Other)
结局指标
主要结局
Maternal Oral Glucose Tolerance Test (OGTT)
时间窗: 27-28 weeks gestation
2 hour OGTT
次要结局
- Maternal Fasting Blood Glucose(34-36 weeks gestation)
- Neonatal Body Composition(Birth - 72 hours)
研究者
研究点 (6)
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