EUCTR2012-005570-56-GB进行中（未招募）1 期
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 over five years in people with non-diabetic hyperglycaemia at high cardiovascular risk. - Glucose Lowering In Non-diabetic hyperglycaemia Trial (GLINT)
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge0 个研究点目标入组 249 人开始时间: 2013年11月14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
- 249
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
入选标准
- •Participants must meet all of the following criteria to participate in the study:
- •Age = 40 years
- •HbA1c =36.6mmol/mol but <47.5mmol/mol, measured within 12 months prior to enrolment
- •Estimated 10-year CVD risk =20% as assessed by the Framingham or QRISK2 scores, measured within 12 months prior to involvement (laboratory values used for the risk calculators should be collected no more than one year prior enrolment)
- •Estimated glomerular filtration rate (eGFR) =45ml/min as determined by the MDRD-4 method and measured within 6 months prior to enrollment
- •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
- •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 (including recording of NHS number and access to Health Episode Statistics (HES))
- •Participant agrees to be tagged for mortality with the Office for National Statistics and to be tagged for:
- •time to first non-melanoma cancer diagnosis (supplied by the National Cancer Registry
- •death due to a non-melanoma cancer cause according to primary/underlying cause of death on death certificate (supplied by the Office of National Statistics)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 6449
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6449
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Unable to provide written consent
- •Prior history of physician-diagnosed Type 2 diabetes.
- •NOTE: Participants with a history of gestational diabetes which resolved after pregnancy are permitted to enrol.
- •Prior history of CVD, defined as:
- •omyocardial infarction, surgical or percutaneous coronary revascularization procedure
- •oStroke (hemorrhagic or ischemic)
- •NOTE: Participants with prior transient ischemic attack or unstable angina are NOT excluded and may be enrolled
- •Participant has a planned or anticipated revascularization procedure within 6 months following enrolment
- •NOTE: Participants with previous peripheral revascularisation procedure are NOT excluded and may be enrolled
- •Participant is pregnant
- •Participant is breastfeeding
- •Participant is currently taking metformin (for any reason) or they have taken metformin in the last 3 months
- •History of cirrhosis of the liver or other significant hepatic impairment, as assessed by medical history
- •End-stage renal disease (CKD stage 3b, eGFR <45ml/min)
- •In the investigator’s 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
- •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.
- •Participant is enrolled 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
相似试验
已完成
不适用
The Glucose Lowering In Non-diabetic hyperglycaemia Trial (GLINT) - Glucose lowering in those at risk of diabetesMetabolic, Cardiovascular, Cancer, Type 2 diabetes.Nutritional, Metabolic, EndocrineNon-insulin-dependent diabetes mellitusISRCTN34875079Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge12,834
已完成
不适用
Study on suppression of blood glucose elevation by consumption of research foods (preliminary test) 3 groups.Healthy adult maleJPRN-UMIN000045463EP Mediate Co., Ltd.9
已完成
不适用
Inhibitory effect on elevation of blood glucose level by bonito dashiMen and women aged from 30 to 70 without a critical disease such as diabetes mellitus and having BMI less than 30.JPRN-UMIN000034776Tenshi College, School of Nursing and Nutrition, Department of Nutrition20
已完成
不适用
Reduction of severe hypoglycaemia with continuous intraperitoneal insulin infusion in type one diabetic patients unsuccessfully treated by continuous subcutaneous insulin infusioDiabetes mellitusDiabetes mellitus type oneNutritional, Metabolic, EndocrineISRCTN68954085Disetronic Medical Systems AG (Switzerland)62
招募中
4 期
Blood-Glucose reduction in Type 2 Diabetes Patients when using two different DPP-4, alogliptin or sitagliptin during 52-week administratioType 2 diabetesJPRN-UMIN000007487Biomedis International Ltd Study Management300