Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00669435
• Other study ID #: UNIPV003DIM2008
• Status: Recruiting
• Phase: Phase 4
• First received: April 25, 2008
• Last updated: April 28, 2008
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: April 2008
• Source: University of Pavia
• Contact: Giuseppe Derosa
• Phone: 39-038-250-2614
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 2009
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Hypertension

Intervention

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

Locations

Country	Name	City	State
Italy	University of Pavia	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Determination of insulin sensitivity, leptin, adiponectin, TNFa, IL6, hsPCR		Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months	Yes