Clinical trial NCT02213224: Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease
Official title: Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)
Keywords: Perindopril,Telmisartan, Efficacy, NAFLD
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cap value of FibroScan （dB/m）
timeFrame: 48 weeks after the treatment
Secondary outcomes:
measure: Angiotensin II
timeFrame: 12, 24, 48 weeks after the treatment
measure: IL-18，IL-1β
timeFrame: 12, 24, 48 weeks after the treatment
measure: aminotransferase
timeFrame: 12, 24, 48 weeks after the treatment
measure: lipids
timeFrame: 12, 24, 48 weeks after the treatment
measure: HOMA-IR
timeFrame: 12, 24, 48 weeks after the treatment
measure: computed tomography value of liver
timeFrame: 48 weeks after the treatment
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Gastroenterology, Nanfang Hospital, Southern Medical University
name: Side Liu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: