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

SLCTR Registration Number

SLCTR/2016/013


Date of Registration

08 Jun 2016

The date of last modification

Dec 06, 2017



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 of Health Condition(s) Studied

Nonalcoholic steatohepatitis (NASH)


Scientific Acronym

None


Public Acronym

None


Brief title

Telmisartan vs. Vitamin E in NASH


Universal Trail 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


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)

Histological activity and fibrosis of the liver on liver biopsy


Primary outcome(s) - Time of assessment(s)

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


Secondary outcome

  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)

Secondary outcome(s) - Time of assessment(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)


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


Recruitment status

Complete


State of ethics review approval

Approved by the Institutional Review Board of theBangabandhu Sheikh Mujib Medical University, Bangladesh on 13.3.2016 (Ref: BSMMU/2016/3054).


Funding source

Bangabandhu Sheikh Mujib Medical University



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