Status:
COMPLETED
Metabolic and Cardiovascular Effects of Armolipid Plus in Subjects With Metabolic Syndrome
Lead Sponsor:
Rottapharm
Conditions:
Metabolic Syndrome
Insulin-resistance
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity in patients with MetS and increased LV mass. 168 patients will be enrolled in this randomized, double-blind, paral...
Detailed Description
Metabolic syndrome (MetS) is a highly prevalent condition characterized by visceral obesity, abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events. Such findings...
Eligibility Criteria
Inclusion
- male and Female 18-70 aged, with diagnosis of metabolic syndrome, defined by the presence of waist circumference \>102 cm (♂) or \>88 cm(♀), and two or more of these criteria:
- fasting blood glucose \>100 mg
- systolic blood pressure \>135 or diastolic blood pressure \>85 mmHg or patients in treatment with antihypertensive drugs
- triglyceridemia \>150 mg/dl
- HDL cholesterolemia \< 40 mg/dl(M), \< 50 mg/dl(F).
- left ventricular hypertrophy: left ventricular mass indexed to height \>44 g/m2,7(♀)or \>48 g/m2(♂).
- antihypertensive and lipid-lowering therapy (if applicaple) stable for at least three months.
- ability to understand and sign an informed consent form.
Exclusion
- pregnancy or lactation period
- diabetes mellitus or pharmacological treatment for this condition
- hepatic failure
- creatininemia \>2mg/dl
- triglyceridemia \>500mg/dl
- severe obesity (BMI \>35)
- chronic renal failure with glomerular filtration rate \<30ml/min
- triglycerides \>500mg/dl
- left ventricular systolic dysfunction (LVEF \<40%)
- hypertrophic cardiomyopathy
- valvular stenosis
- previous myocardial infarction with acinesie
- intermediate or severe cardiac valve disorders
- intolerance to any components of Armolipid Plus
- pacemaker generated arrhythmia
- Inadequately controlled high blood pressure during therapy optimization (SBP \>140mmHg or DBP \>90mmHg)
- patients with comorbidities are allowed (e.g. ischemic heart disease, dysthyroidism) but they have got to be in stable therapy for at least 3 months and they did not have major clinical events in the last three months;
- heart failure.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT02295176
Start Date
April 1 2013
End Date
July 1 2015
Last Update
October 27 2015
Active Locations (3)
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1
Domenico Bonaduce
Naples, Naples, Italy, 80131
2
Ferruccio Galletti
Naples, Italy
3
Giuseppe Schillaci
Terni, Italy