Continuous Glucose Monitoring in Myo-inositol Supplemented Obese Pregnant Individuals: a Feasibility Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Glucose levels
研究概览
简要总结
Myoinositol is an insulin-like compound that is present in both plant and animal cells. Humans synthesize it naturally, but it is also obtained in our diet. It works through an intracellular signaling pathway to increase insulin sensitivity. Myoinositol has been used as an over-the-counter (OTC) supplement in the management of polycystic ovarian syndrome due to this effect. Myoinositol has also been shown to improve glycemic profiles in pregnant euglycemic women and well as improve insulin sensitivity in pregnant patients with gestational diabetes mellitus (GDM).
This is a double blind RCT offering myo-inositol or placebo to those who are eligible and enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton gestations
- •Women aged > 18 years and < 45 years
- •Recruited before 16 weeks gestation
- •Obese (pre-pregnancy BMI ≥ 30)
- •Receiving prenatal care at Tufts Medical Center
- •Planning to give birth at Tufts Medical Center
- •Can tolerate glucose tolerance test
- •Willing and able to wear CGM
- •Willing and able to sign informed consent
排除标准
- •Multiple gestation
- •Preexisting diabetes
- •Taking medications that impact body weight or metabolism (eg metformin)
- •Inability to tolerate glucose tolerance test
- •Adults unable to consent (cognitively impaired adults)
- •Wards of the state
- •Non-viable neonates
- •Neonates of uncertain viability
结局指标
主要结局
Glucose levels
时间窗: 1 year
Average glucose levels during CGM monitoring period for those enrolled
Eligibility
时间窗: 1 year
proportion of screened women who were eligible
次要结局
未报告次要终点