Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

Study Overview
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Brief Summary
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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.

Official Title
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Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Losartan + Simvastatin
* Drug: Amlodipine + Simvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Amlodipine and Simvastatin | Drug: Amlodipine + Simvastatin<br>* tablets; 5, 10 mg; od; 12 months tablets; 20 mg; od; 6 months<br>|
| Experimental: 2<br>Losartan and Simvastatin | Drug: Losartan + Simvastatin<br>* tablets; 50, 100 mg; od; 12 months tablets; 20 mg; od; 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Essential hypertension, Liver steatosis