EUCTR2016-001644-19-IE进行中（未招募）1 期
A Randomised Placebo Controlled Trial of the effectiveness of Early MEtformin in Addition to Usual Care in the Reduction of Gestational Diabetes Mellitus Effects (EMERGE)
ational University of ireland Galway0 个研究点目标入组 535 人开始时间: 2016年8月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 535
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Inclusion Criteria:
- •a)Willing and able to provide written informed consent
- •b)Participants aged 18-50 years
- •c)Pregnancy gestation up to 28 weeks (+ 6 days) confirmed by positive pregnancy test
- •d)Singleton pregnancy as determined by scan
- •e)Positive diagnosis of Gestational Diabetes Mellitus on a OGTT according to IADPSG criteria if any one of the following are achieved:
- •a.Fasting glucose >/= 5.1mmol/l and <7mmol/l, or
- •b.1 hour post glucose load of >/=10mmol/l, or
- •c.2 hour post glucose load of >/=8.5 mmol/l and <11.1mmol/l
- •f)Resident in the locality and intending to deliver within the trial site
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 535
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria:
- •Women who meet any one or more of the following exclusion criteria will not be eligible to take part in the trial:
- •a)Participants who have an established diagnosis of diabetes (Type 1, Type 2, Monogenic or secondary)
- •b)Participants with a fasting glucose = 7mmol/l or a 2h value = 11.1 mmol/l
- •c)Multiple pregnancies (twins, triplets etc.) as determined by scan
- •d)Known intolerance to metformin
- •e)Known contraindication to the use of metformin which include:
- •i.renal insufficiency (defined as serum creatinine of greater than 130 µmol/L or creatinine clearance <60 ml/min)
- •ii.moderate to severe liver dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times the upper limit of normal)
- •iii.shock or sepsis, and
- •iv.previous hypersensitivity to metformin
- •f)Major congenital malformations or an abnormality deemed unsuitable for metformin by the site PI or attending consultant
- •g)Known small for gestational age1
- •h)Known current gestational hypertension, pre-eclampsia, or ruptured membranes
- •i)Participants who have a history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements
- •j)Participants with significant gastrointestinal problems such as severe vomiting, Crohn’s disease or colitis which will inadvertently affect absorption of the study drug
- •k)Participants with congestive heart failure or history of congestive heart failure
- •l)Participants with serious mental illness which would affect adherence to study medication or compliance with study protocol in the opinion of the investigator
- •m)Women with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •1Small for gestational age (SGA) refers to fetal growth less than the 10th percentile (RCOG, 2014), or if foetal growth is deemed unsatisfactory by the treating obstetrician.
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