Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Cap value of FibroScan （dB/m）
研究概览
简要总结
The aim of this current study was to assess the therapeutic effects of perindopril and telmisartan for hypertensive patients with NAFLD and make comparison between the therapeutic effects of these two kind of drugs.
This study is a randomized parallel control clinical trial which would be carried out in Nanfang Hospital, Southern Medical University.
About one hundred and eighty patients would be randomly assigned to perindopril,telmisartan and amlodipine three groups.
详细描述
Inclusion criteria:
18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD; The patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients agreed to participate in the trial and signed the informed consent.
Exclusion criteria:
There are no coexisting causes for chronic liver disease, such as viral, alcoholic,drug-induced and autoimmune liver diseases; Patients with diabetes mellitus; Patients with serious primary diseases; Patients with mental disorder or can not take the medicine regularly; Pregnancy and nursing mothers; Allergic constitution or intolerance to ACEIs or ARBs drugs. Outcome measures include Cap value of FibroScan,angiotensin II,IL-18，IL-1β,aminotransferase,lipids and HOMA-IR.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-70 years old patients who were diagnosed with mild-moderate hypertension and NAFLD;
- •The patients did not take ACEIs or ARBs drugs six weeks before the inclusion; Patients agreed to participate in the trial and signed the informed consent.
排除标准
- •There are no coexisting causes for chronic liver disease, such as viral, alcoholic,drug-induced and autoimmune liver diseases;
- •Patients with diabetes mellitus; Patients with serious primary diseases; Patients with mental disorder or can not take the medicine regularly;
- •Pregnancy and nursing mothers;
- •Allergic constitution or intolerance to ACEIs or ARBs drugs.
研究组 & 干预措施
Perindopril
Perindopril 4mg qd taken in the morning;
干预措施: Perindopril (Drug)
Telmisartan
Telmisartan 80mg qd taken in the morning;
干预措施: Telmisartan (Drug)
Amlodipine
Amlodipine；5mg qd taken in the morning.
干预措施: Amlodipine (Drug)
结局指标
主要结局
Cap value of FibroScan （dB/m）
时间窗: 48 weeks after the treatment
FibroScan examination would be performed in all patients 48 weeks after administration of the drugs, and Cap value of FirbroScan will be recorded.
次要结局
- lipids(12, 24, 48 weeks after the treatment)
- computed tomography value of liver(48 weeks after the treatment)
- Angiotensin II(12, 24, 48 weeks after the treatment)
- aminotransferase(12, 24, 48 weeks after the treatment)
- IL-18，IL-1β(12, 24, 48 weeks after the treatment)
- HOMA-IR(12, 24, 48 weeks after the treatment)