Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease

Nonalcoholic Fatty Liver Disease (NAFLD) Clinical Trial

— NF-NAFLD  

Official title:

Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02213224
• Other study ID #: NAFLD20140805
• Status: Recruiting
• Phase: Phase 4
• First received: August 6, 2014
• Last updated: August 8, 2014
• Start date: August 2014
• Est. completion date: September 2017

Study information

• Verified date: August 2014
• Source: Nanfang Hospital of Southern Medical University
• Contact: Side Liu, MD,PhD
• Phone: +86 020 61641537
• Email: liuside2011[@]163.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Nonalcoholic Fatty Liver Disease (NAFLD)

Intervention

Drug:
• Perindopril
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.
• Telmisartan
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.
• Amlodipine
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.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cap value of FibroScan (dB/m)	FibroScan examination would be performed in all patients 48 weeks after administration of the drugs, and Cap value of FirbroScan will be recorded.	48 weeks after the treatment	No
Secondary	Angiotensin II		12, 24, 48 weeks after the treatment	No
Secondary	IL-18,IL-1ß		12, 24, 48 weeks after the treatment	No
Secondary	aminotransferase		12, 24, 48 weeks after the treatment	No
Secondary	lipids		12, 24, 48 weeks after the treatment	No
Secondary	HOMA-IR	homeostasis model assessment of insulin resistance (HOMA-IR)	12, 24, 48 weeks after the treatment	No
Secondary	computed tomography value of liver		48 weeks after the treatment	No