膳食肌醇补充对胰岛素抵抗和预防妊娠糖尿病的影响：一项随机对照试验的研究方案。
Effect of dietary myo-inositol supplementation on the insulin resistance and the prevention of gestational diabetes mellitus: study protocol for a randomized controlled trial.
机构信息
First Department of Obstetrics and Gynecology, National and Kapodistrian University of Athens, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.
Endocrine Section - Diabetes Centre, Alexandra Hospital, 80 Vasilissis Sofias Avenue, Athens, Greece.
出版信息
Trials. 2020 Jul 9;21(1):633. doi: 10.1186/s13063-020-04561-2.
BACKGROUND
Gestational diabetes mellitus (GDM) is defined as impaired glucose tolerance with onset or first recognition during pregnancy, which is characterized by an increased insulin resistance. Gestational diabetes mellitus is associated with pregnancy-related maternal and fetal morbidity (both antenatal and perinatal). Myo-inositol has been suggested to improve insulin resistance in women with polycystic ovary syndrome. The aim of this study is to examine the impact of myo-inositol supplementation during pregnancy on the incidence of gestational diabetes mellitus.
METHODS
We will conduct a single-center, open-label, randomized controlled trial. A total of 160 healthy pregnant women with singleton pregnancy at 11-13 weeks of gestation will be randomly allocated in two groups: intervention group (N = 80) and control group (N = 80). The intervention group will receive myo-inositol and folic acid (4000 mg myo-inositol and 400 mcg folic acid daily) from 11 to 13 weeks of gestation until 26-28 weeks of gestation, while the control group will receive folic acid alone (400 mcg folic acid daily) for the same period of time as intervention group. The primary outcome will be gestational diabetes incidence rate at 26-28 weeks of gestation, according to the results of a 75 g oral glucose tolerance test held at 26-28 weeks of gestation. The secondary outcomes will include fasting blood glucose levels, glycated hemoglobin levels, insulin resistance level (evaluated by homeostasis model assessment of insulin resistance and Matsuda Index), and incidence rate of diet-treated gestational diabetes and diabetes requiring insulin therapy at 26-28 weeks of gestation.
DISCUSSION
This trial will provide evidence for the effectiveness of myo-inositol supplementation during pregnancy in reducing the incidence of gestational diabetes mellitus.
TRIAL REGISTRATION
ISRCTN registry: ISRCTN16142533 . Registered on 9 March 2017.
背景
妊娠期糖尿病（GDM）是指在妊娠期间出现或首次诊断的葡萄糖耐量受损，其特征为胰岛素抵抗增加。妊娠期糖尿病与妊娠相关的母婴发病率（产前和围产期）有关。肌醇已被证明可改善多囊卵巢综合征女性的胰岛素抵抗。本研究旨在探讨妊娠期补充肌醇对妊娠期糖尿病发病率的影响。
方法
我们将进行一项单中心、开放标签、随机对照试验。共有 160 名 11-13 孕周的单胎妊娠健康孕妇将被随机分为两组：干预组（N=80）和对照组（N=80）。干预组从 11 周到 13 周开始每天服用肌醇和叶酸（4000mg 肌醇和 400μg 叶酸），直至 26-28 孕周，而对照组在相同时间内仅服用叶酸（每天 400μg）。主要结局为 26-28 孕周时的妊娠期糖尿病发病率，根据 26-28 孕周时进行的 75g 口服葡萄糖耐量试验结果判断。次要结局包括空腹血糖水平、糖化血红蛋白水平、胰岛素抵抗水平（通过稳态模型评估的胰岛素抵抗和 Matsuda 指数评估），以及 26-28 孕周时饮食治疗的妊娠期糖尿病和需要胰岛素治疗的糖尿病发病率。
讨论
本试验将为妊娠期补充肌醇降低妊娠期糖尿病发病率的有效性提供证据。
试验注册
ISRCTN 注册：ISRCTN80114223。于 2017 年 3 月 9 日注册。
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