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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

• Drug: Losartan + Simvastatin
  • tablets; 50, 100 mg; od; 12 months tablets; 20 mg; od; 6 months
• Drug: Amlodipine + Simvastatin
  • tablets; 5, 10 mg; od; 12 months tablets; 20 mg; od; 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Amlodipine and Simvastatin
• Experimental: 2
  • Losartan and Simvastatin

Primary Measures

• 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.
  • Time Frame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
    Safety Issue?: Yes

Secondary Measures

• Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR
  • Time Frame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Pavia

Overall Clinical Trial Officials and Contacts

Overall Contact: Giuseppe Derosa 39-038-250-2614 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00669435

Study ID Number: UNIPV003DIM2008

ClinicalTrials.gov Identifier: NCT00669435

Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health