Identification of genetic and functional biomarkers that predict PPAR-gamma-associated fluid retention and oedema

niversity of Dundee0 个研究点开始时间: 2008年8月12日最近更新: 2012年3月19日

试验速览

暂无简介。

•Once selected from the DARTS database, patients must fulfill all of the following criteria:
•1.Between 30 and 70 inclusive
•2.Type 2 diabetes mellitus
•3.Non-insulin dependent
•4.BMI 20-35 kg/m2
•5.HbA1c =15% within last 12 months
•6.BP =160/100 mmHg
•7.Ability to understand and willingness to sign the informed consent form
•8.Willing to discontinue oral agents for 2 weeks prior to the study
•9.Willing to initiate TZD therapy for the duration of the study
•Patients in cohort 1 must fulfill the following criterion:
•1.Genotype Pro12Ala variant of the PPAR-gamma gene
•Patients in cohort 2 must fulfill the following criterion:
•1.Genotype Pro12Pro of the PPAR-gamma gene
•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) no
•F.1.3.1 Number of subjects for this age range

•Patients in both cohorts are to be excluded from the study if they meet any of the following criteria:
•1.Patients with existing peripheral oedema
•2.Pregnant or lactating women
•3.Known to be HIV-positive
•4.Known active hepatitis B and/or hepatitis C infection
•5.Patients currently receiving diuretics and/or calcium channel blockers
•6.History of symptomatic heart failure (NYHA Classes II, III, IV) or LV systolic ejection fraction <40%)
•7.Acute cardiovascular event within 6 months before screening including myocardial infarction, cerebrovascular accident, cardiac disturbance, evidence of acute or unstable chronic pulmonary disease or lesions at chest radiograph
•8.History of TZD intolerance or currently receiving TZD therapy
•9.Significant renal or hepatic dysfunction (>2.5 xULN ALT; creatinine >130 µmol/L)
•10.Known drug/alcohol abuse
•11.Known psychiatric condition
•12.Patients requiring insulin therapy or more than 2 oral anti-diabetic drugs
•13.Microalbuminuria (as detected by standard clinical screening methods)
•14.Patients with severe varicose veins

发起方

niversity of Dundee