Hypertension
Conditions
Keywords
Essential hypertension, Liver steatosis
Brief summary
Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be added to both groups. The aim of this study is to evaluate the effect of losartan and simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or obese hypertensive normocholesterolemic patients with hepatic steatosis.
Interventions
DRUGLosartan + Simvastatin
tablets; 50, 100 mg; od; 12 months tablets; 20 mg; od; 6 months
DRUGAmlodipine + Simvastatin
tablets; 5, 10 mg; od; 12 months tablets; 20 mg; od; 6 months
Sponsors
University of Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Gender: 50% Male and 50% female * Age: 40-80 years * Race: Caucasian * Overweight or obese: respectively BMI25-30 kg/m2 or BMI \> 30 kg m2 * Hypertensive: PA \> 140/90 mmHg * Normocholesterolemic (LDL\< 160 mg/dl HDL \> 35 mg/dl) * Liver steatosis
Exclusion criteria
* other antihypertensive treatment after wash out period of 2 weeks * abnormal heart rest function (EF \< 55%). * valvular heart disease * congenital heart disease * heart failure or prior myocardial infarction * diabetes * renal disease * liver disease * connective tissue disease * pregnancy or lactation * serious adverse experience * sensitivity to the study drugs or its components * contraindication from an approved label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All patients will undergo anthropometric evaluation and abdominal ultrasonography (performed by the same examiner); will be taken routine liver US and US measurement of visceral and subcutaneous fat. | Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR | Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months |
Countries
Italy
Contacts
Primary ContactGiuseppe Derosa
Outcome results
None listed