Celentano Claudio, Matarrelli Barbara, Pavone Giulia, Vitacolonna Ester, Mattei Peter A, Berghella Vincenzo, Liberati Marco
Department of Obstetrics and Gynaecology, University of Chieti, Chieti, Italy.
Department of Medicine and Science of Aging, University of Chieti, Chieti, Italy.
J Matern Fetal Neonatal Med. 2020 Mar;33(5):743-751. doi: 10.1080/14767058.2018.1500545. Epub 2018 Dec 17.
To identify the effects of different dietary inositol stereoisomers on insulin resistance and the development of gestational diabetes mellitus (GDM) in women at high risk for this disorder. A preliminary, prospective, randomized, placebo controlled clinical trial. Nonobese singleton pregnant women with an elevated fasting glucose in the first or early second trimester were studied throughout pregnancy. Supplementation with myo-inositol, d-chiro-inositol, combined myo- and d-chiro-inositol or placebo. Development of GDM on a 75 grams oral glucose tolerance test at 24-28 weeks' gestation. Secondary outcome measures were increase in BMI, need for maternal insulin therapy, macrosomia, polyhydramnios, neonatal birthweight and hypoglycemia. The group of women allocated to receive myo-inositol alone had a lower incidence of abnormal oral glucose tolerance test (OGTT). Nine women in the control group (C), one of the myo-inositol (MI), five in d-chiro-inositol (DCI), three in the myo-inositol/D-chiro-inositol group (MI/DCI) required insulin ( = .134). Basal, 1-hour, and 2 hours glycemic controls were significantly lower in exposed groups ( < .001, .011, and .037, respectively). The relative risk reduction related to primary outcome was 0.083, 0.559, and 0.621 for MI, DCI, and MI/DCI groups. This study compared the different inositol stereoisomers in pregnancy to prevent GDM. Noninferiority analysis demonstrated the largest benefit in the myo-inositol group. The relevance of our findings is mainly related to the possibility of an effective approach in GDM. Our study confirmed the efficacy of inositol supplementation in pregnant women at risk for GDM.
确定不同膳食肌醇立体异构体对胰岛素抵抗以及高危女性妊娠期糖尿病(GDM)发生发展的影响。一项初步、前瞻性、随机、安慰剂对照临床试验。对孕早期或孕中期空腹血糖升高的非肥胖单胎孕妇进行全程研究。补充肌醇、D-手性肌醇、肌醇与D-手性肌醇联合制剂或安慰剂。在妊娠24 - 28周时进行75克口服葡萄糖耐量试验以评估GDM的发生情况。次要结局指标包括体重指数增加、母体胰岛素治疗需求、巨大儿、羊水过多、新生儿出生体重及低血糖。单独接受肌醇治疗的女性组口服葡萄糖耐量试验(OGTT)异常的发生率较低。对照组(C)有9名女性、肌醇组(MI)有1名、D-手性肌醇组(DCI)有5名、肌醇/D-手性肌醇组(MI/DCI)有3名女性需要胰岛素治疗(P = 0.134)。暴露组的基础血糖、1小时血糖和2小时血糖控制水平显著更低(分别为P < 0.001、0.011和0.037)。MI组、DCI组和MI/DCI组与主要结局相关的相对风险降低分别为0.083、0.559和0.6。本研究比较了孕期不同肌醇立体异构体预防GDM的效果。非劣效性分析表明肌醇组获益最大。我们研究结果的相关性主要与GDM有效治疗方法的可能性有关。我们的研究证实了补充肌醇对GDM高危孕妇的疗效。