PRESERVE TRIAL: Pancreatic beta-cell dysfunction REStorEd by Rosiglitazone and Valsartan Effects; A 52-week randomized controlled factorial study in subjects with impaired fasting glucose and/or impaired glucose tolerance - PRESERVE

VU University Medical Centre0 个研究点开始时间: 2007年12月12日最近更新: 2012年3月19日

试验速览

暂无简介。

•One-hundred and forty-four male and female subjects (aged 35-70 years) with impaired fasting glucose (IFG; plasma glucose > or = 6.1 and < 7.0 mmol/l) and/or subjects with IFG (plasma glucose > or = 5.6 and < 7.0 mmol/l) and a family history of DM2 (i.e. first and second degree (i.e. grandparents) relatives), and/or impaired glucose tolerance (2-h plasma glucose during 75-g OGTT 7.8-11.1 mmol/l) are eligible.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Drug use: current use of ACE-i, ARB and/or TZD's, inability to discontinue these medications; Known hypersensitivity to the study drugs; prior use of blood glucose lowering medications; use of systemic glucocorticoids.
•Cardiovascular Disease: uncontrolled hypertension requiring ACE-i or ARB; ejection fraction known to be <40% or congestive heart failure, or existing clinical cardiovascular disease.
•Other criteria: history of DM (except gestational DM); renal or hepatic disease; major illness with life expectancy <5 years; use of other experimental drugs; pregnant; disease/ medications that affect glucose tolerance; unwillingness to be randomized or sign informed consent; known uncontrolled substance abuse; inability to understand study information and/or communicate with clinical staff.

发起方

VU University Medical Centre