Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis
Information source: University of Pavia
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Losartan + Simvastatin (Drug); Amlodipine + Simvastatin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of Pavia Overall contact:
Giuseppe Derosa, Phone: 39-038-250-2614
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.
Clinical Details
Official title: Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Giuseppe Derosa, Phone: 39-038-250-2614
University of Pavia, Pavia, Italy; Recruiting
Giuseppe Derosa, MD, Phone: 39-038-250-2614
Additional Information
Starting date: April 2008
Ending date: April 2009
Last updated: April 28, 2008
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