Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
1
Amlodipine and Simvastatin
干预措施: Amlodipine + Simvastatin (Drug)
2
Losartan and Simvastatin
干预措施: Losartan + Simvastatin (Drug)
结局指标
主要结局
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.
时间窗: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
次要结局
- Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR(Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months)