Nonalcoholic Fatty Liver Disease in Morbidly Obese Patients

August 15, 2019 updated by: Taipei Medical University Hospital

Predictors of Improvement of Nonalcoholic Fatty Liver Disease in Morbidly Obese Patients Undergoing Bariatric Surgery

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of abnormal liver biochemistry tests in the world. The prevalence rate of NAFLD has been reported to be 30-40% in men and 15-20% in women, up to 70% of people with type 2 diabetes mellitus (Type 2 DM) and even surpassing 74% to 90% of morbidly obese patients with body mass index (BMI) higher than 35 kg/m^2. The primary aims of this prospective cohort study would evaluate the predictive factors of successful weight reduction, NAFLD and nonalcoholic steatohepatitis (NASH) improvement in a large cohort of morbidly obese patients undergoing bariatric surgery. Secondarily, the diagnostic accuracy of noninvasive serum markers, doppler ultrasonography and transient elastography would be validated. Thirdly, we would conduct gene expression analyses to elucidate biological pathways underlying NAFLD phenotypes in this unique cohort.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This prospective study have been approved by Taipei Medical University-Joint Institutional Review Board. The starting point for each patient is the day of surgery and the end-point is 1 year after the operation. During bariatric surgery, all patients would undergo a liver biopsy under laparoscopic guidance. The diagnosis of NASH and liver fibrosis would be made histologically. For histological examinations, liver tissue specimens would be fixed in 10 % formalin, embedded in paraffin, and then stained with hematoxylin and eosin. A detailed history wound be obtained including history of alcohol use, type 2 DM, hypertension, or hyperlipidemia. Written informed consents would be obtained from all patients who would agree to undergo surgery. A histologic assessment would be planned approximately 1 year after bariatric surgery, if patient would agree.

In this study, excess weight loss (EWL) is defined as the excess weight over the ideal body weight calculated according to the Metropolitan Life Weight Tables. The weight reduction success would be defined as the percentage of excess weight loss (%EWL) >50% at the point of 1 year after operation. Diagnosis and classification of type 2 DM is based on criteria established by the American Diabetes Association. The individual components of glycemic control (levels of serum glucose, HbA1c levels) body weight, waist circumference, and blood pressure would be examined. Additionally, the levels of total cholesterol, LDL-C, triglyceride, uric acid, aspartate aminotransferase (AST),alanine aminotransferase (ALT), albumin, insulin, C-peptide, iron, calcium, complete blood cell counts would be assessed 1 day before surgery and 12 months post-operatively. All patients would receive abdominal ultrasonography, duplex doppler ultrasonography, transient elastography (FibroScan®) before and 12 months after bariatric surgery. The diagnosis accuracy of transient elastography (FibroScan®) would be validated. Transient elastography (FibroScan®) appears to be a non-invasive, reproducible, and reliable method for predicting liver fibrosis, in patients with hepatitis B virus, hepatitis C virus, NAFLD and alcoholic liver disease.

Patients body weight would be measured in light clothing without shoes to the nearest 0.1 kg, and body height would be measured to the nearest 0.1 cm. BMI is calculated as weight in kilograms divided by height in meters squared. Waist circumference would be measured midway between the lateral lower rib margin and the superior anterior iliac crest.

Study Type

Observational

Enrollment (Anticipated)

200

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Morbidly obese patient undergoing bariatric surgery

Description

Inclusion Criteria:

  • Adult male and female Morbidly obese patients age 20-65 years with BMI over 37.5 kg/m^2, or BMI over 32.5 kg/m^2 with comorbidity other than diabetes (hypertension, NASH, dyslipidemia, obstructive sleep apnea, osteoarthritis joint…etc.) or BMI over 27.5 kg/m^2 with poor control diabetes undergoing bariatric surgery

Exclusion Criteria:

  • The presence of end organ damage
  • Previous bariatric surgery
  • Women who are pregnant or nursing
  • Prolonged exposure to known hepatotoxins such as alcohol or drugs
  • Concurrent hepatitis B virus, hepatitis C virus, hepatitis D virus, or human immunodeficiency virus infection
  • Concurrent autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis
  • Wilson disease or hemochromatosis

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Morbidly obese patients with NAFLD
Morbidly obese patient with Nonalcoholic fatty liver disease. The starting point for each patient is the day of surgery and the end-point is 1 year after the operation. During bariatric surgery, all patients would undergo a wedge liver biopsy under laparoscopic guidance. The diagnosis of NASH would be made histologically.
Procedure: Bariatric surgery
During bariatric surgery, all patients would undergo a wedge liver biopsy under laparoscopic guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from body mass index (BMI) at 12 months after surgery
Time Frame: pre-surgery and 12 months after surgery
The BMI would be calculated by dividing the body weight (in kilograms) by the square body height (in meters).
pre-surgery and 12 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from alanine aminotransferase at 12 months after surgery
Time Frame: pre-surgery and 12 months after surgery
Liver function test
pre-surgery and 12 months after surgery
Change from aspartate aminotransferase at 12 months after surgery
Time Frame: pre-surgery and 12 months after surgery
Liver function test
pre-surgery and 12 months after surgery
Nonalcoholic steatohepatitis
Time Frame: 1 day of surgery
The diagnosis of nonalcoholic steatohepatitis (NASH) would be made histologically. A score for steatosis, activity and fibrosis would be given to each patient for the diagnosis of NASH as in Bedossa's study. (Reference: Hepatology. 2012 Nov;56(5):1751-9.)
1 day of surgery

Collaborators and Investigators

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

Sponsor

Taipei Medical University Hospital

Investigators

  • Study Chair: Weu Wang, M.D.&PhD, Comprehensive weight management center, Taipei Medical University hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

October 1, 2016

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

August 15, 2019

First Posted (Actual)

August 16, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201601029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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