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临床试验/EUCTR2007-007491-42-IT
EUCTR2007-007491-42-IT进行中(未招募)不适用

GAMMAGLUTAMYLTRANSFERASE: CHARACTERIZATION OF ITS ISOFORMS IN DYSLIPIDEMICS UNDERGOING LIPID-LOWERING TREATMENT - ISOGT STUDY

Istituto Fisiologia Clinica, CNR0 个研究点开始时间: 2008年4月15日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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
All

入选标准

  • 1) Age 20-80 years; 2) dislipidemiae; 3) cholesterol LDL > 120 mg/dl and/or 4) cholesterol HDL < 40 mg/dl for men and 50 mg/dl for women and/or 5) triglycerides >= 150 mg/dl; 6)in the absence of pharmacological therapy with statins and fibrates (or therapeutic wash-out for at least 3 months). Patients might also suffer from 1 or more of the following pathology: a)Modified fasting glycemia (fasting glycemia >= 110 mg/dl) following a dietetics and/or a stable pharmacological therapy (insulin and/or oral hypoglycaemic) for at least 6 months; b) arterial hypertension (>= 130/85 mmHg) under control, with diet or stable pharmacological treatment for at least 6 months; c) body overweight/obesity (BMI > 25 Kg/mq) and/or abdominal obesity: men waistline > 102 cm, women waistline > 88 cm, following a dietetic treatment; d) ischemic heart disease and/or multivessels atherosclerosis (as anamnestic data: previous angina/IMA) or proved by eco-doppler of neck vessels and/or abdominal aorta and/or peripheral vessels (absence of left ventricular dysfunction, EF > 50 %, proved by basal eco-cardiogram made within 6 months since the beginning of the study).
  • 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

排除标准

  • 1) Acute or chronic heart failure (EF < 50% associated at heart failure's signs or symptoms); 2) hepato-biliary pathology (hepatitis B and C, biliary lithiasis, cirrhosis etc.) with increase of transaminases > 2.5 times upper normal limit; 3) chronic renal failure (creatinine level >1.5 mg/dl and/or clearance of creatinine < 30 ml/h); 4) alcoholism; ; 5) neoplastic pathology previous and present; 6) systemic inflammatory pathology active; 7) myopathy or familiar history of hereditary muscular pathology; 8) pregnancy and/or nursing; 9) statins or fibrates treatment during the recruitment and/or during the 3 months preceding the beginning of the study; 10) statins or fibrates anamnestic intolerance or previous adverse effects with statins or fibrates use; 11) ciclosporin therapy during the recruitment; 12) glitazones and replaglinide therapy.

研究者

发起方
Istituto Fisiologia Clinica, CNR

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