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

• Conditions: Dislipidemiae (hypercholesteremia, hypertriglyceridemia or mixed forms); MedDRA version: 9.1Level: LLTClassification code 10061227Term: Lipid metabolism disorder

• Registration Number: EUCTR2007-007491-42-IT
• Lead Sponsor: Istituto Fisiologia Clinica, CNR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified