Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease

Overview

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.

Full Title of Study: “Evaluation of Perindopril and Telmisartan for the Treatment of Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: September 2016

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

  • 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.
  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Perindopril
    • Perindopril 4mg qd taken in the morning;
  • Experimental: Telmisartan
    • Telmisartan 80mg qd taken in the morning;
  • Placebo Comparator: Amlodipine
    • Amlodipine;5mg qd taken in the morning.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • Angiotensin II
    • Time Frame: 12, 24, 48 weeks after the treatment
  • IL-18,IL-1β
    • Time Frame: 12, 24, 48 weeks after the treatment
  • aminotransferase
    • Time Frame: 12, 24, 48 weeks after the treatment
  • lipids
    • Time Frame: 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)
  • computed tomography value of liver
    • Time Frame: 48 weeks after the treatment

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Nanfang Hospital, Southern Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Side Liu, MD,PhD, Principal Investigator, Department of Gastroenterology, Nanfang Hospital, Southern Medical University
  • Overall Contact(s)
    • Side Liu, MD,PhD, +86 020 61641537, liuside2011@163.com

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