Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease (NF-NAFLD)

August 8, 2014 updated by: Nanfang Hospital of Southern Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • GuangZhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
        • Principal Investigator:
          • Side Liu, MD.PhD
        • Sub-Investigator:
          • Yue Li, MD
        • Sub-Investigator:
          • Xu Li, MD
        • Sub-Investigator:
          • Zelong Han, MD
        • Sub-Investigator:
          • Wen Xu, MM
        • Sub-Investigator:
          • Yubin Guo, MM
        • Sub-Investigator:
          • Feng Xiong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Perindopril
Perindopril 4mg qd taken in the morning;
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.
Other Names:
  • Perindopril; brand name: Acertil, serial number:H20034053
Experimental: Telmisartan
Telmisartan 80mg qd taken in the morning;
Drug: 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.
Other Names:
  • Telmisartan; brand name: Micardis, serial number:J20090089
Placebo Comparator: Amlodipine
Amlodipine；5mg qd taken in the morning.
Drug: 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.
Other Names:
  • Amlodipine；5mg qd taken in the morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cap value of FibroScan （dB/m）
Time Frame: 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.
48 weeks after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Angiotensin II
Time Frame: 12, 24, 48 weeks after the treatment
12, 24, 48 weeks after the treatment
IL-18，IL-1β
Time Frame: 12, 24, 48 weeks after the treatment
12, 24, 48 weeks after the treatment
aminotransferase
Time Frame: 12, 24, 48 weeks after the treatment
12, 24, 48 weeks after the treatment
lipids
Time Frame: 12, 24, 48 weeks after the treatment
12, 24, 48 weeks after the treatment
HOMA-IR
Time Frame: 12, 24, 48 weeks after the treatment
homeostasis model assessment of insulin resistance (HOMA-IR)
12, 24, 48 weeks after the treatment
computed tomography value of liver
Time Frame: 48 weeks after the treatment
48 weeks after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: Side Liu, MD,PhD, Department of Gastroenterology, Nanfang Hospital, Southern Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 8, 2014

First Posted (Estimate)

August 11, 2014

Study Record Updates

Last Update Posted (Estimate)

August 11, 2014

Last Update Submitted That Met QC Criteria

August 8, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAFLD20140805

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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