Department of Nutrition and Bioprogramming, Instituto Nacional de Perinatología "Isidro Espinosa de los Reyes", Montes Urales 800, Mexico City 11000, Mexico.
Departamento de Salud, Universidad Iberoamericana, Ciudad de México, Prolongación Paseo de la Reforma 880, Mexico City 01219, Mexico.
Nutrients. 2021 Dec 24;14(1):62. doi: 10.3390/nu14010062.
The aim of this study was to examine the efficacy of intensive medical nutrition therapy (MNT) plus metformin in preventing gestational diabetes mellitus (GDM) among high-risk Mexican women. An open-label randomized clinical trial was conducted. Inclusion criteria were pregnant women with three or more GDM risk factors: Latino ethnic group, maternal age >35 years, body mass index >25 kg/m, insulin resistance, and a history of previous GDM, prediabetes, a macrosomic neonate, polycystic ovarian syndrome, or a first-degree relative with type 2 diabetes. Women before 15 weeks of gestation were assigned to group 1 ( = 45): intensive MNT-plus metformin (850 mg twice/day) or group 2 ( = 45): intensive MNT without metformin. Intensive MNT included individual dietary counseling, with ≤50% of total energy from high carbohydrates. The primary outcome was the GDM incidence according to the International Association of Diabetes Pregnancy Study Groups criteria. There were no significant differences in baseline characteristics and adverse perinatal outcomes between the groups. The GDM incidence was = 11 (24.4%) in the MNT plus metformin group versus = 7 (15.5%) in the MNT without metformin group: = 0.42 (RR: 1.57 [95% CI: 0.67-3.68]). There is no benefit in adding metformin to intensive MNT to prevent GDM among high-risk Mexican women. Clinical trials registration: NCT01675310.
本研究旨在探讨强化医学营养治疗（MNT）联合二甲双胍在预防墨西哥高危女性妊娠期糖尿病（GDM）中的疗效。进行了一项开放标签随机临床试验。纳入标准为具有以下三种或以上 GDM 危险因素的孕妇：拉丁裔族群、母亲年龄>35 岁、体重指数（BMI）>25 kg/m、胰岛素抵抗以及既往 GDM、前驱糖尿病、巨大儿、多囊卵巢综合征病史，或有 2 型糖尿病家族史。孕 15 周前的女性被分配至 1 组（n=45）：强化 MNT 联合二甲双胍（850 mg 每日两次）或 2 组（n=45）：强化 MNT 不联合二甲双胍。强化 MNT 包括个体饮食咨询，总能量中碳水化合物的比例≤50%。主要结局为根据国际妊娠糖尿病研究协会标准得出的 GDM 发生率。两组间基线特征和不良围产期结局无显著差异。MNT 联合二甲双胍组的 GDM 发生率为 11 例（24.4%），MNT 不联合二甲双胍组为 7 例（15.5%）：=0.42（RR：1.57[95%CI：0.67-3.68]）。在高危墨西哥女性中，强化 MNT 联合二甲双胍并不能预防 GDM。临床试验注册：NCT01675310。
