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Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis

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ClinicalTrials.gov Identifier: NCT00669435
Recruitment Status : Unknown
Verified April 2008 by University of Pavia.
Recruitment status was:  Recruiting
First Posted : April 30, 2008
Last Update Posted : April 30, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Losartan + Simvastatin Drug: Amlodipine + Simvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients
Study Start Date : April 2008
Actual Primary Completion Date : April 2008
Estimated Study Completion Date : April 2009


Arm Intervention/treatment
Active Comparator: 1
Amlodipine and Simvastatin
Drug: Amlodipine + Simvastatin

tablets; 5, 10 mg; od; 12 months

tablets; 20 mg; od; 6 months

Experimental: 2
Losartan and Simvastatin
Drug: Losartan + Simvastatin

tablets; 50, 100 mg; od; 12 months

tablets; 20 mg; od; 6 months




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669435


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

Locations
Italy
University of Pavia Recruiting
Pavia, Italy
Contact: Giuseppe Derosa, MD    39-038-250-2614      
Sponsors and Collaborators
University of Pavia

Responsible Party: Giuseppe Derosa/MD, University of Pavia
ClinicalTrials.gov Identifier: NCT00669435     History of Changes
Other Study ID Numbers: UNIPV003DIM2008
First Posted: April 30, 2008    Key Record Dates
Last Update Posted: April 30, 2008
Last Verified: April 2008

Keywords provided by University of Pavia:
Essential hypertension
Liver steatosis

Additional relevant MeSH terms:
Hypertension
Fatty Liver
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Amlodipine
Losartan
Simvastatin
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists