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临床试验/NCT02149992
NCT02149992Unknown不适用

Glycemic Impact of Myo-inositol in High Risk and Gestational Diabetic Pregnancies: a Pilot Study

Oregon Health and Science University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
overall mean glucose

研究概览

简要总结

Myo-inositol has been shown to decrease the rate of diabetes in pregnancy in European studies. It is not known exactly how this occurs or what it does to the sugar when the supplement is taken. This study purpose is to look at the patient's sugar levels while taking the supplement to see if the overall levels of sugar go down. We hypothesize that in addition to sugar levels, other hormones influencing diabetes will be altered.

详细描述

Myo-inositol is important for glucose homeostasis and has been shown to improve insulin sensitivity. This is a prospective cohort pilot study to determine daily glycemic pharmacokinetics and metabolic influences of myo-inositol supplementation using continuous glucose monitoring system (CGMS) and pre- and post-supplement blood work in high risk pregnancies and women diagnosed with gestational diabetes mellitis (GDM). Risk factors include: obesity, previous pregnancy with GDM, family history of diabetes, glucose intolerance, and polycystic ovarian syndrome (PCOS). Women will have a CGMS device placed on day one and begin with 3 days of placebo plus folic acid (400mcg) to determine baseline glycemia and metabolic levels. For the final 4 days, women with take myo-inositol supplementation (4g) plus folic acid (400mcg). The CGMS device will be removed on day 7 when final blood work will be obtained. Self-capillary glucose testing 4 times per day is recorded to calibrate CGMS glucose values. These observations will help determine the effects of myo-inositol on overall mean glucose and other metabolic factors in high risk and GDM patients, identify pharmacokinetic discipline in pregnancy, and develop the groundwork for future prospective clinical trials for the prevention and/or augmentation in treatment GDM.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • English-speaking
  • singleton
  • pregnant females between 20-28 weeks of gestation at time of enrollment PLUS (either of the following)
  • High risk including women must have passed routine glucose screening and have greater than or equal to 1 of the following high risk criteria: first degree family member with diabetes mellitus, previous pregnancy with gestational diabetes, PCOS, or body mass index great than or equal to
  • Gestational diabetes diagnosed in current pregnancy based on IADPSG or NIH consensus diagnostic recommendation

排除标准

  • pre-pregnancy diagnosis of diabetes mellitus
  • renal disease
  • immunocompromised
  • currently taking immunosuppressive medications
  • age <13 years old
  • non-English speaking
  • multifetal gestation.

结局指标

主要结局

overall mean glucose

时间窗: 7 days

Difference in overall mean glucose with folic acid alone versus myo-inositol+folic acid supplementation; measured by continuous glucose monitoring system started pre-supplementation and continued for 4 days after supplementation.

次要结局

  • metabolic differences(1,4,7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Valent

DO; Assistant Professor

Oregon Health and Science University

研究点 (2)

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