The Effect of Spironolactone and Vitamin E Versus Vitamin E on Serum Adipocytokines Levels in Patients With Biopsy-proven Nonalcoholic Fatty Liver Disease-A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serum adipocytokines levels
研究概览
简要总结
The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E on serum levels of adipokines 52 weeks post-treatment.
详细描述
Unlike other chronic liver diseases (e.g., hepatitis C), there are no effective treatment strategy for NAFLD. Currently, the management of NAFLD includes modification of underlying risk factors, detection of patients that have progressed to cirrhosis, management of cirrhosis-related morbidity and transplantation in patients with end-stage liver disease. Diet, exercise, bariatric surgery and pharmacologic treatment, including weight loss agents, insulin sensitizers, lipid-lowering agents, ursodeoxycholic acid and vitamin E have been investigated with some promising results.
The renin-angiotensin-aldosterone system (RAAS) has been implicated in the pathogenesis of insulin resistance (IR) and nonalcoholic fatty liver disease (NAFLD). Recently, low-dose (25-50 mg/day) aldosterone antagonists in patients with heart failure diminish mortality, possibly by reducing cardiac and vascular fibrosis. Moreover, the beneficial effect of spironolactone in a mouse model with diet-induced diabetes and NAFLD has been reported. However, to our knowledge, the role of spironolactone in NAFLD patients has not been investigated yet.
The primary aim of the study is the effect of spironolactone and vitamin E versus vitamin E on serum levels of adipokines 52 weeks post-treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Bright liver on ultrasound imaging and increased liver function tests for at least 6 months before liver biopsy
- •Biopsy-proven NAFLD (either NAFL or NASH) according to NAFLD Activity Score (NAS)
排除标准
- •Ethanol consumption more than 20 g/day
- •Known intolerance to spironolactone or vitamin E
- •History of liver disease (chronic viral hepatitis, autoimmune hepatitis, drug-induced liver disease, primary biliary cirrhosis, hemochromatosis, Wilson's disease and α1-antitrypsin deficiency)
- •Previous exposure to hepatotoxic drugs
- •Spironolactone or vitamin E administration within one year before screening
- •Type I Diabetes Mellitus
- •Pancreatitis
- •Uncontrolled hypothyroidism or hyperthyroidism
- •Adrenal Insufficiency
- •Renal Failure
- •Pregnancy
- •Exclusion criteria were generally the same as those proposed for PIVENS trial design with two modifications: a) known intolerance to spironolactone as an exclusion criterion and b) the inclusion of patients with T2DM not receiving thiazolidinediones or insulin.
研究组 & 干预措施
Vitamin E
Vitamin E, capsules 400 mg daily, for 52 weeks
干预措施: Spironolactone/Vitamin E (Drug)
结局指标
主要结局
Serum adipocytokines levels
时间窗: 52 weeks
Adiponectin; visfatin; leptin; resistin; omentin; vaspin; RBP4; TNF-alpha, IL-6; IL-1
次要结局
- Insulin resistance(52 weeks)
- Hormonal profile(52 weeks)
- Serum homocysteine levels(52 weeks)
- Liver histology(52 weeks)
- Serum biochemistry(52 weeks)
- Reactive Oxygen Metabolites (ROMs)(52 weeks)
研究者
Stergios A. Polyzos
Dr
Aristotle University Of Thessaloniki