The Comparison of Effect Between Salsalate and Placebo in Osteoarthritis With Nonalcoholic Fatty Liver Disease: Investigator Initiated Randomized Placebo-controlled Double-blind, Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change of controlled attenuation parameter
研究概览
简要总结
This Study purpose to verify change of variety factors that the cause of nonalcoholic fatty liver disease and its process through salsalate injection to osteoarthritis patient who has non alcoholic fatty liver
详细描述
Salsalate, the salicylic acid dimer that is one of anti-inflammatory and kind of salicylate. Aspirin(Acetylated salicylic) is known as nonsteroidal anti-inflammatory, also salsalate is widely used painkiller and anti-inflammatory without prescription in Europe and America through the long time and it was approved as osteoarthritis and rheumarthritis treatment in Korea. Especially salsalate is switched to salicylic acid(active metabolite) 15% rate lower than the same dose of aspirin (3.5g vs. 5g).
Salsalate is cyclooxygenase antagonist, it make anti-inflammatory effect by hinder creation of variety inflammatory induction factors like interleukin-6, Tumor Necrosis Factor (TNF)-alpha, C-reactive protein. This anti-inflammatory reaction is known to block Nuclear Factor(NF)-kappaB gene action by hinder action of IkappaB kinase. Also salsalate was reported it has positive effect to gluco metabolism as performed role of insulin-sensitizing. Therefore, the above mechanism of salsalate was expected that it can be had positive effect to metabolic disease like diabetes and obesity, and related studies are performed considerably at present.
There is no clinical trial for non alcoholic fatty acid related salsalate, and there was the animal study result that salsalate may reduce occurence of non alcoholic fatty acid and fibrosis by hinder non alcoholic fatty acid creation and inflammation mediation path.
Therefore, this Study purpose to verify change of variety factors that the cause of nonalcoholic fatty liver disease and its process through salsalate injection to osteoarthritis patient who has non alcoholic fatty liver
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)
盲法说明
Double-Blind
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis patient who has non alcoholic fatty liver
- •Standard of non alcoholic fatty liver diagnosis
- •Fatty liver on abdominal ultrasonography
- •Patient who has no evidence as hepatitis B, hepatitis C, immune hepatitis, metabolic hepatitis and other chronic hepatitis
- •Osteoarthritis patient who has never been treated
排除标准
- •Unsuitable on inclusion criteria
- •Thiazolidinedione injected patient for diabetes treatment or patient who has changed injected drug last 6 month
- •Patient who is treating nonsteroidal antiinflammatory drugs for osteoarthritis
- •Renal dysfunction : serum creatinine level 1.5mg/dl or creatinine clearance < 60ml/min
- •Anamnesis of gastrointestinal tract bleeding
- •Upper 5 times(200IU/l) the normality of Aspartate Transaminase(AST), Alanine Transaminase(ALT)
- •Pregnant or Breastfeeding
- •Patient who has untreated malignant tumor
- •Liver transplantation patient
- •Patient who has liver function Child-Pugh B over
- •Patient who has serious disease that was estimated influence to study (e.g. Congestive heart failure, Kidney failure, Chronic pancreatitis, Malignant tumor)
- •Patients who has been injected immunomodulatory and immunosuppressant(inclusive universal corticosteroids) before 6 month enrollment or at present
- •Patient who was judged unsuitable for study by investigator
研究组 & 干预措施
Salsalate
17 patients received continuous medication with salsalate 2g/day after run-in period
干预措施: Salsalate (Drug)
Placebo
17 patients received continuous medication with Placebo 2g/day after run-in period
干预措施: Placebo (Other)
结局指标
主要结局
Change of controlled attenuation parameter
时间窗: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
Change of adipokine as Adiponectin
时间窗: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
Change of hepatokine as Fetuin-A
时间窗: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
Change of pulse wave velocity
时间窗: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
次要结局
- Change of controlled attenuation parameter(baseline and 4weeks)
- Change of pulse wave velocity(baseline and 4weeks)
- Numerical value change of fatty liver index(baseline, 4weeks and 8weeks)
- Numerical value change of hepatic fibrosis as Nonalcoholic Fatty Liver Disease(NAFLD) fibrosis score(baseline, 4weeks and 8weeks)
- Change of hepatokine as Fetuin-A(baseline and 4weeks)
- Change of adipokine as Adiponectin(baseline and 4weeks)
- Change of lipid metabolic factors as Cholesterol, Triglyceride, LDL-cholesterol HDL-cholesterol and liver function test as Aspartate Transaminase(AST) and Alanine Transaminase(ALT)(baseline, 4weeks and 8weeks)
- Stability comparison like side effect(Up to 2month)
- Change of saccharometabolic factors as Homeostasis Model Assessment(HOMA)-Insulin Resistance(IR), Homeostasis Model Assessment(HOMA)-B, Fasting glucose, Insulin, C-peptide, HbA1c, Glycated albumin(baseline, 4weeks and 8weeks)
- Change of function of osteoarthritis as WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index)(baseline, 4weeks and 8weeks)
- Change of liver fibrosis factors as hyaluronic acid(baseline, 4weeks and 8weeks)
- Change of symptom of osteoarthritis as visual analog score for pain(baseline, 4weeks and 8weeks)
- Change of inflammatory factors as C Reactive Protein(CRP), Tumor Necrosis Factor(TNF)-a(baseline, 4weeks and 8weeks)
研究者
Ji Hoon Kim
Associate professor
Korea University Guro Hospital