Department of Human Pathology, University of Messina, Messina, Italy.
Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
Sci Rep. 2021 Apr 23;11(1):8866. doi: 10.1038/s41598-021-88329-x.
To verify whether myo-inositol plus α-lactalbumin may reduce insulin resistance and excessive fetal growth in women with gestational diabetes mellitus. In a 12-month period, 120 women with a diagnosis of gestational diabetes mellitus were consecutively enrolled with an allocation of 1:1 in each group and randomly treated with myo-inositol plus α-lactalbumin plus folic acid (treated group) or folic acid (control group) for 2 months. Primary outcome was the variation of insulin resistance through the study evaluated by HOMA-IR. Secondary outcome was the evaluation, through the study, of fetal growth by ultrasound measurements of abdominal circumference centiles and estimated fat thickness. Some clinical outcomes were also considered. After 2 months, in the treated group, a significant reduction in insulin resistance (HOMA values 3.1 ± 1.4 vs 6.1 ± 3.4, p = 0.0002) and fetal growth was shown (Abdominal circumference centiles 54.9 ± 23.5 vs 67.5 ± 22.6, P = 0.006). Among clinical outcomes, a significant decrease in the rate of women who needed insulin (6.7% vs 20.3%, p = 0.03) and of pre-term birth (0 vs 15.2%, p = 0.007) was evidenced. A combination of myo-inositol and α-lactalbumin may reduce insulin resistance and excessive fetal growth.Clinical trial registration: ClinicalTrials.gov, http://www.clinicaltrials.gov , NCT03763669, first posted date 04/12/2018; last posted date December 06/12/2018.
为了验证肌醇加α-乳白蛋白是否可以降低妊娠糖尿病患者的胰岛素抵抗和胎儿过度生长。在 12 个月的时间里，连续纳入了 120 名被诊断为妊娠糖尿病的女性，按照 1:1 的比例分配到两组，随机接受肌醇加α-乳白蛋白加叶酸（治疗组）或叶酸（对照组）治疗 2 个月。主要结局是通过 HOMA-IR 评估研究期间胰岛素抵抗的变化。次要结局是通过超声测量腹围百分位数和估计脂肪厚度评估胎儿生长。还考虑了一些临床结局。治疗 2 个月后，治疗组胰岛素抵抗显著降低（HOMA 值从 3.1±1.4 降至 6.1±3.4，p=0.0002），胎儿生长也有所减缓（腹围百分位数从 54.9±23.5 降至 67.5±22.6，P=0.006）。在临床结局中，需要胰岛素的女性比例显著下降（6.7%对 20.3%，p=0.03），早产率也显著下降（0 对 15.2%，p=0.007）。肌醇和α-乳白蛋白的联合使用可能会降低胰岛素抵抗和胎儿过度生长。临床试验注册：ClinicalTrials.gov，http://www.clinicaltrials.gov，NCT03763669，首次注册日期 2018 年 4 月 12 日；最后注册日期 2018 年 12 月 6 日。
