ISRCTN34875079已完成未知
Glucose Lowering In Non-diabetic hyperglycaemia Trial (GLINT) - a randomised controlled trial to establish the effectiveness and cost-effectiveness of metformin in preventing cardiovascular events in people with non-diabetic hyperglycaemia at high risk over five years
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 个研究点目标入组 12,834 人开始时间: 2012年12月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 12,834
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29652246
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participants must meet all of the following criteria to participate in the study:
- •1. Men and women with non-diabetic hyperglycaemia (HbA1c equal to or greater than 5.5% but <6.5% within 6 months prior to enrolment), aged 40 years or older
- •2. Estimated 10-year cardiovascular disease (CVD) risk equal to or greater than 20% (Framingham / QRISK2)
- •3. Estimated glomerular filtration rate (eGFR) >45ml/min as determined by the MDRD-4 method and measured within 6 months prior to enrolment
- •4. Participant understands the study procedures, alternative treatments available, and the risks involved with the study, and voluntarily agrees to participate by providing written informed consent
- •5. Participant agrees to allow study staff to contact his or her General Practitioner and/or consultant to notify them of study participation and to obtain all medical records necessary for complete data ascertainment during the follow-up period.
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •1. Prior history of physician-diagnosed diabetes.
- •Note: Participants with a history of gestational diabetes which resolved after pregnancy are permitted to enrol.
- •2. Prior history of CVD, defined as:
- •2.1. Myocardial infarction, surgical or percutaneous coronary revascularisation procedure
- •2.2. Stroke (haemorrhagic or ischemic)
- •Note: Participants with prior transient ischemic attack or unstable angina are NOT excluded and may be enrolled
- •3. Participant has a planned or anticipated revascularisation procedure within 6 months following enrolment
- •Note: Participants with previous peripheral revascularisation procedure are NOT excluded and may be enrolled
- •4. Participant is pregnant
- •5. History of cirrhosis of the liver or other significant hepatic impairment, as assessed by medical history
- •6. End-stage renal disease
- •7. In the investigators opinion, participant has a medical history that indicates a life expectancy of <2 years or might limit the individual's ability to take the trial treatments for the duration of the study
- •8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
- •9. Participant is enroled in or has participated within 12 weeks prior to enrolment in another experimental protocol involving the use of an investigational drug or device or an intervention that would interfere with the conduct of the trial.
研究者
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