Nonalcoholic Fatty Liver Disease (NAFLD)
Conditions
Keywords
Perindopril,Telmisartan, Efficacy, NAFLD
Brief summary
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.
Detailed description
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.
Interventions
DRUGPerindopril
Perindopril is a kind of angiotensin converting enzyme inhibitors (ACEIs) which has been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.
DRUGTelmisartan
Telmisartan is a kind of angiotensin receptor blockers (ARBs) which has also been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.
DRUGAmlodipine
Amlodipine is also a kind of widely used first-line drugs for the treatment of hypertension, and there is no evidence showing that it is effective for NAFLD.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cap value of FibroScan （dB/m） | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-18，IL-1β | 12, 24, 48 weeks after the treatment | — |
| aminotransferase | 12, 24, 48 weeks after the treatment | — |
| Angiotensin II | 12, 24, 48 weeks after the treatment | — |
| HOMA-IR | 12, 24, 48 weeks after the treatment | homeostasis model assessment of insulin resistance (HOMA-IR) |
| computed tomography value of liver | 48 weeks after the treatment | — |
| lipids | 12, 24, 48 weeks after the treatment | — |
Countries
China
Contacts
Primary ContactSide Liu, MD,PhD
Outcome results
None listed