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NCT Number: NCT01828528

Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease

The purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and after bariatric surgery. The investigators also aim to study the short-term effect of bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric surgery.

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Key information

Conditions

Nonalcoholic Fatty Liver Disease Body Weight Body Weight Changes Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nonalcoholic Steatohepatitis Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Liver Disease Center, Sheba Medical Center, Tel-Hashomer

Ramat Gan, 52621, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 20≤ age ≤80
  • BMI>35kg/m2
  • Men and women
  • Fatty infiltration in liver ultrasonography

Exclusion criteria

  • Alcohol drinking > 140g/week
  • Presence of hepatitis B or C or HIV
  • Known liver disease such as:
  • Wilson's disease
  • hemochromatosis
  • α1-antitrypsin deficiency
  • autoimmune liver disease
  • primary biliary cirrhosis
  • primary sclerosing cholangitis)

Treatment and study plan

Sleeve gastrectomy

Procedure

An intra-operative liver biopsy was performed in 20 patients

Primary outcomes

  1. Change from baseline liver steatosis, steatohepatitis and fibrosis at different stages after bariatric surgery, measured by non-invasive measurements as described below.

    Time frame: Baseline is defined as three weeks to one month before surgery. Different stages to compare to baseline are as following: 8-12 days and 12, 24 and 48 weeks after surgery.

    Measurements to be performed to assess liver disease stage at baseline and at 8-12 days and 12, 24 and 48 weeks after surgery:

    • Blood tests of liver functions (Alanine transaminase, Aspartate transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase, ferritin, prothrombin-time (PT), international normalized ratio (INR), Total/Direct Bilirubin, Albumin, uric acid), lipids profile (total cholesterol, triglycerides, HDL, LDL) and diabetes biomarkers (insulin, glucose, HbA1c).
    • Blood tests of adiponectin (only at baseline and 48 weeks after surgery).
    • Fibroscan test for quantifying liver fibrosis by means of elastography (only at baseline and 48 weeks after surgery).
    • A blood test (FibroMax) for determining the stage and grade of liver damage (only at baseline and at 24 and 48 weeks after surgery).
    • OWLiver® test (a serum based test that can discriminate NAFLD from steatohepatitis using metabolomics) at baseline and 48 weeks after surgery.

Secondary outcomes

  1. Change of postoperative cardiovascular risk compared to baseline.

    Time frame: Baseline is defined as three weeks to one month before surgery. Change will be assessed 6-12 months after surgery.

    Patients will undergo brachial artery flow-mediated dilation (FMD) test (surrogate marker for endothelial function and cardiovascular risk).

  2. Change in cholecystokinin levels before and after the surgery.

    Time frame: Baseline levels of cholecystokinin at 1-2 days before surgery compared to 8-12 days after surgery.

    In addition, gastric cholecystokinin levels will be measured from the removed stomach tissue.

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

The Impact of Bariatric Surgery on Nonalcoholic Fatty Liver Disease and Cardiovascular Risk Utilizing Non-invasive Measures

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2013
Registry last updated
Nov 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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