Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

Phase 4

• Conditions: Hypertension
• Interventions: Drug: Amlodipine + Simvastatin; Drug: Losartan + Simvastatin

• Registration Number: NCT00669435
• Lead Sponsor: University of Pavia

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-04
• Study Start: 2008-04
• Primary Completion: 2008-04
• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-28
• Last Update Submitted: 2008-04-28
• Study First Posted: 2008-04-30
• Last Update Posted: 2008-04-30
• Study Completion: 2009-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Amlodipine + Simvastatin	Amlodipine and Simvastatin
2	Losartan + Simvastatin	Losartan and Simvastatin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR	Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months

Trial Locations

Locations (1)

University of Pavia; 🇮🇹 Pavia, Italy