The study of offspring and mothers with gestational diabetes treated with metformin or glibenclamide in a randomized controlled trial after 9 years

Praveen G. Paul, Beena Kingsbury, Hilda Yenuberi, R. Tirkey, S. Benjamin, S. Rathore, Babuji Manimegalai, A. Belavendra, J. Mathews
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Abstract

Introduction: Follow-up of the mothers and their offspring recruited to a randomized controlled trial comparing neonatal outcomes in women with gestational diabetes treated with metformin or glibenclamide was conducted 9 years ago. A significant decrease in neonatal hypoglycemia in the group treated with metformin was seen in the original study. Methodology: Results of clinical examination, blood sample collection, and dual-energy X-ray absorptiometry (DEXA) scan not published in a brief communication are described in this study. The nutritional status was assessed using a 3-day recall method using the Indian Food Composition Table 2017. The physical activity of offspring was assessed using the Global Physical Activity Questionnaire. Results: The overall follow-up rate of the cohort was 49% and similar in both the groups. The anthropometric details, blood tests, and DEXA in the women and their offspring were similar except that the offspring of the group on metformin had higher triglyceride values than the offspring of the women treated with glibenclamide. The average body mass index of the offspring was similar and was 18. Currently, women who were treated with glibenclamide 9 years ago had higher fasting plasma glucose levels (9.2 [7.3, 12.6]) than the metformin group (7.2 [6.1, 8.4] median [interquartile range]), P = 0.02. They also had significantly higher diastolic blood pressure readings 77.1mmHg (8.9) and 72.1mmHg (11.7) mean (SD), P = 0.035. (Information from the previously published brief communication). Conclusion: No significant adverse outcome was seen in women treated with metformin and the offspring 9 years later.
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在一项为期9年的随机对照试验中,二甲双胍或格列本脲治疗妊娠期糖尿病的后代和母亲的研究
9年前,一项随机对照试验对接受二甲双胍或格列本脲治疗的妊娠期糖尿病妇女的新生儿结局进行了随访。在最初的研究中,二甲双胍治疗组新生儿低血糖显著降低。方法:临床检查、血样采集和双能x线吸收仪(DEXA)扫描的结果未在简短的通讯中发表。根据2017年印度食品成分表,采用3天召回法评估营养状况。使用全球身体活动问卷对后代的身体活动进行评估。结果:队列总体随访率为49%,两组随访率相近。除了二甲双胍组的后代的甘油三酯值高于格列本脲组的后代外,这些妇女及其后代的人体测量细节、血液测试和DEXA相似。后代的平均体重指数相似,均为18。目前,9年前接受格列本脲治疗的女性空腹血糖水平(9.2[7.3,12.6])高于二甲双胍组(7.2[6.1,8.4]中位数[四分位数范围]),P = 0.02。他们的舒张压读数也显著升高,平均77.1mmHg(8.9)和72.1mmHg (11.7), P = 0.035。(资料来自先前公布的简短来文)。结论:二甲双胍治疗的妇女及其后代9年后未见明显不良结局。
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