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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

Mar 03, 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.
  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


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