Effect of dietary myo-inositol supplementation on the insulin resistance and the prevention of gestational diabetes mellitus: study protocol for a randomized controlled trial
Effect of dietary myo-inositol supplementation on the insulin resistance and the prevention of gestational diabetes mellitus: study protocol for a randomized controlled trial
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DOI：
10.1186/s13063-020-04561-2
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发表时间：
2020-07-09
期刊：
影响因子：
2.5
通讯作者：
Daskalakis, George
中科院分区：
文献类型：
--
作者：
Asimakopoulos, George;Pergialiotis, Vasilios;Daskalakis, George
背景资料：妊娠期糖尿病（GDM）是指妊娠期发生或首次发现的糖耐量异常，其特征是胰岛素抵抗增加。妊娠期糖尿病与妊娠相关的母亲和胎儿的发病率（产前和围产期）。肌醇已被建议，以改善多囊卵巢综合征妇女的胰岛素抵抗。本研究的目的是检查的影响，肌醇补充妊娠期糖尿病的发病率。方法：我们将进行一项单中心，开放标签，随机对照试验。将160例孕11-13（+6）周单胎妊娠的健康孕妇随机分为两组：干预组（N = 80）和对照组（N = 80）。干预组将从妊娠11至13（+6）周接受肌醇和叶酸（每天4000 mg肌醇和400 mcg叶酸），直到妊娠26-28周，而对照组将接受叶酸（每天400 mcg叶酸），时间与干预组相同。主要结局将是妊娠26- 28周时的妊娠期糖尿病发病率，根据妊娠26-28周时进行的75 g口服葡萄糖耐量试验的结果。次要结局将包括空腹血糖水平、糖化血红蛋白水平、胰岛素抵抗水平（通过胰岛素抵抗的稳态模型评估和Matsuda指数评估），以及饮食治疗的妊娠糖尿病和妊娠26-28周时需要胰岛素治疗的糖尿病的发病率。本试验将为妊娠期间补充肌醇在降低妊娠期糖尿病发病率方面的有效性提供证据。
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(+6)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(+6)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.