Home » Trials » SLCTR/2016/013


Randomized clinical trial on efficacy of telmisartan compared to vitamin E on histopathological improvement in patients with nonalcoholic steatohepatitis.

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SLCTR Registration Number

SLCTR/2016/013


Date of Registration

08 Jun 2016

The date of last modification

Jan 29, 2019



Application Summary


Scientific Title of Trial

Randomized clinical trial on efficacy of telmisartan compared to vitamin E on histopathological improvement in patients with nonalcoholic steatohepatitis.


Public Title of Trial

Randomized clinical trial on efficacy of telmisartan compared to vitamin E on histopathological improvement in patients with nonalcoholic steatohepatitis.


Disease or Health Condition(s) Studied

Nonalcoholic steatohepatitis (NASH)


Scientific Acronym

None


Public Acronym

None


Brief title

Telmisartan vs. Vitamin E in NASH


Universal Trial Number

U1111-1181-7526


Any other number(s) assigned to the trial and issuing authority

ERC: BSMMU/2016/3054


Trial Details


What is the research question being addressed?

What is the efficacy of telmisartan compared to vitamin E on histopathological improvement in patients with nonalcoholic steatohepatitis?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 4


Intervention(s) planned

The study will be carried out at the Department of Hepatology Bangabandhu Sheikh Mujib Medical University.

Consenting participants meeting the inclusion/exclusion criteria will be randomized into 2 arms.

Arm A will receive telmisartan 40mg daily for a period of one year.

Arm B will receive vitamin E 800mg daily in two divided doses for a period of one year.

All patients will be advised to undergo moderate exercise (30 minute walk) daily. They will also receive dietary advice to avoid fatty foods and excessive sugar in the diet.

Diabetic patients will be treated with life style modification, oral antidiabetic agents or insulin according to standard guidelines. Antidiabetic agents that have shown benefit in NASH such as metformin and thiazolidinediones will be avoided. Dyslipidaemia and hypertension will be treated according to standard guidelines.


Inclusion criteria

  1. Ultrasonographic evidence of fatty liver
  2. NAFLD activity score (NAS) greater than or equal to 5 on liver biopsy.

Exclusion criteria

  1. Significant alcohol intake (more than 20 gm/day).
  2. History of taking drugs that may cause fatty liver (i.e. tamoxifen, valproic acid, amiodarone, methotrexate)
  3. History of taking drugs that have shown benefit in previous NASH pilot studies (i.e. metformin, thiazolidinediones, fibrates).
  4. Chronic liver disease due to any cause (HBV, HCV, Wilson’s disease, drug induced liver injury etc.).
  5. Pregnancy.
  6. Co-morbid conditions such as (COPD, CKD, CCF etc.)
  7. History of recent MI (within 3 months).
  8. Liver failure
  9. Hypothyroidism.
  10. Patient who fails to give consent for paired liver biopsy.


Primary outcome(s)

  1. Histological activity and fibrosis of the liver on liver biopsy

    [

    At baseline and the end of 12 months from initiation of the intervention

    ]

Secondary outcome(s)

    1. Blood pressure (BP)
    2. Body mass index (BMI)
    3. Complete blood count
    4. Erythrocyte sedimentation rate (ESR)
    5. Fasting blood glucose (FBG)
    6. Hepatic arterial blood flow
    7. Prothrombin time with INR
    8. Lipid profile (TC, TG,HDL,LDL)
    9. Insulin resistance (HOMA-IR)
    10. Serum aspartate transaminase (AST) and alanine transaminase (ALT)
    11. Gamma-glutamyl transferase (GGT)
    [

    Outcomes 1 and 2 will be assessed at baseline, monthly for 3 months and then every 3 months for a total of 12 months.

    Outcomes 3-9 will be assessed at baseline and at the end of 12 moths.

    Outcomes 10 and 11 will be assessed at baseline and then every 3 months for a total of 12 months.

    ]

Target number/sample size

40 (20 in each arm)


Countries of recruitment

Bangladesh


Anticipated start date

2016-06-20


Anticipated end date

2018-01-31


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Bangabandhu Sheikh Mujib Medical University


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2016-03-13


Approval number

BSMMU/2016/3054


Details of Ethics Review Committee

Name: Institutional Review Board of the Bangabandhu Sheikh Mujib Medical University
Institutional Address: BSMMU, Shahbag, Dhaka -1000, Bangladesh
Telephone: +880-9661064
Email: registrar@bsmmu.edu.bd


Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr Mushfiqul Abrar
Resident Phase B, MD (Hepatology) course
Department of Hepatology, Bangabandhu Sheikh Mujib Medical University, Shahbag, Dhaka - 1000, Bangladesh.
Tel: +880-2-9662198.

Fax: +880-2-8111069
Email: mushfiq.bsmmu.r4@gmail.com

Contact Person for Public Queries

Dr. Shahinul Alam
Associate Professor of Hepatology
Bangabandhu Sheikh Mujib Medical University
Tel: +880-2-9662198


Email: shahinul67@yahoo.com


Primary study sponsor/organization

Bangabandhu Sheikh Mujib Medical University

Shahbag, Dhaka-1000, Bangladesh
Tel:+880-2-9661065
Fax: +880-2-5516569
Email: registrar@bsmmu.edu.bd
Web: http://www.bsmmu.edu.bd

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results