Trial document




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  DRKS00017085

Trial Description

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Title

Influence of bariatric surgery on NAFLD

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Trial Acronym

BariNASH

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study investigates the impact of bariatric surgery on non-alcoholic steatohepatitis (NASH) after bariatric surgery.
Obesity and associated co-morbidities are seen an increasing concern of our population and health care system. NASH is a manifestation of the metabolic syndrome in the liver. It goes in line with a higher risk for chronic impaired liver function, cancer, and even the need of liver transplantation.
Patients who undergo primary bariatric surgery are included in the study. Therefore, liver, subcutaneous and visceral fat tissue, sonographic measures, blood, and stool are investigated. 1 and 3 years after surgery another biopsy is taken percutaneously. 1, 2 and 3 years after surgery the remaining tests are repeated.
The aim of this study is to show an improvement of advanced NASH (with fibrosis) 1 and 3 years after bariatric surgery. In addition, results of histologic findings are correlated with sonographic and blood tests.

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Brief Summary in Scientific Language

The aim of this study is to show an improvement of non-alcoholic steatohepatitis (NASH) and associated fibrosis 1 and 3 years after bariatric surgery.
Non-alcoholic fatty liver disease (NAFLD) is one of the most common liver diseases worldwide with a prevalence of 30 % in Europe. Main risk factors are the metabolic syndrome including obesity, dyslipidemia, insulin resistance, diabetes mellitus type II, sitting behavior, and unhealthy diet. The prevalence is 50-90% amongst obese people. NAFLD is considered to be the hepatic manifestation of the metabolic syndrome. The more aggressive NASH develops in 10-20% of patients with NAFLD. Patients suffering from NASH have a higher risk for fibrosis or even cirrhosis. 25-30% of patients with NASH cirrhosis develop a hepatocellular carcinoma (HCC). 25-30% of patients with NASH cirrhosis decease by direct disease complications or need a live saving liver transplantation.
The diagnostic gold standard to date is the liver biopsy alongside the metabolic parameters’ checkup.
Bariatric surgery is the most effective and long-term treatment of obesity and its related co-morbidities. Amelioration of NASH after bariatric surgery has been shown in the literature. However, long-term effects have not yet been studied thoroughly especially in patients with aggressive steatohepatitis or even fibrosis.
All patients who are scheduled for primary bariatric procedure in our hospital and gave their written informed consent are screened for fibrosis F>1 by liver biopsy taken during surgery. After 1 and 3 years another percutaneous liver biopsy is taken. In addition, histology is correlated with sonographic measures (incl. ARFI), blood and stool tests, and diabetic and cardiovascular risk factors.
Primary outcome is defined as the improvement of fibrosis (>1 degree of fibrosis) 1 and 3 years after bariatric surgery.
Secondary outcome is the histologic improvement of NASH (reduction of NAS>1), cardiovascular risk profile reduction, including blood pressure setting, anti-hypertensive and anti-diabetic co-medication, and the degree of obesity 1 and 3 years after bariatric surgery. Additionally, histologic measures are correlated with sonographic measures.

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Organizational Data

  •   DRKS00017085
  •   2019/05/06
  •   [---]*
  •   yes
  •   Approved
  •   8244_BO_S_2019, Ethikkommission der Medizinischen Hochschule Hannover
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   E66.09 -  [generalization E66.0: Obesity due to excess calories]
  •   K75.8 -  Other specified inflammatory liver diseases
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Interventions/Observational Groups

  •   Biopsy of the liver, visceral and subcutaneous fat, blood sample, stool sample, ultrasound (ARFI, FirboScan), oGTT, questionaire
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome is defined as the improvement of fibrosis (>1 degree of fibrosis) 1 and 3 years after bariatric surgery.

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Secondary Outcome

Secondary outcome is the histologic improvement of NASH (reduction of NAS>1), cardiovascular risk profile reduction, including blood pressure setting, anti-hypertensive and anti-diabetic co- medication, and the degree of obesity 1 and 3 years after bariatric surgery. Additionally, histologic measures are correlated with sonographic measures.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/06/03
  •   103
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Primary elective bariatric operation
• Obesity with a BMI >35kg/m2 (obesity >II)
• Patient volunteers >=18 years of age and consentable

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Exclusion Criteria

• Known primary liver diseases other than NASH: viral hepatitis, autoimmune hepatitis, Morbus Wilson, hemochromatosis, alcoholic steatohepatitis, primary biliary cirrhosis, primary sclerosing cholangitis
• Involvement in another study investigating NASH
• Alcohol abuse (> 20g/d for women, 40 g/d for men)
• Redo-operations
• Diabetes mellitus Typ 1
• Liver-toxic medication
• Not willing to give informed consent

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Addresses

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    • Klinikum Nordstadt, Klinikum Region Hannover GmbHKlinik f. Allgemein-, Viszeral- und Gefäß- und Adipositas(AVGA)chirurgie
    • Mr.  Prof.Dr.med.  Julian  Mall 
    • Haltenhoffstr. 41
    • 30167  Hannover
    • Germany
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    • Medizinische Hochschule Hannover (MHH)Zentrum Innere MedizinKlinik für Gastroenterologie, Hepatologie und Endokrinologie
    • Ms.  Katharina  Hupa 
    • Carl-Neuberg-Str. 1
    • 30625   Hannover
    • Germany
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    • Klinikum Nordstadt, Klinikum Region Hannover GmbHKlinik f. Allgemein-, Viszeral- und Gefäß- und Adipositas(AVGA)chirurgie
    • Ms.  Clara  Böker 
    • Haltenhoffstr. 41
    • 30167  Hannover
    • Germany
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    end of 1:1-Block address contact scientific-contact
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    • Klinikum Nordstadt, Klinikum Region Hannover GmbHKlinik f. Allgemein-, Viszeral- und Gefäß- und Adipositas(AVGA)chirurgie
    • Ms.  Clara  Böker 
    • Haltenhoffstr. 41
    • 30167  Hannover
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum Nordstadt, Klinikum Region Hannover GmbHKlinik f. Allgemein-, Viszeral- und Gefäß- und Adipositas(AVGA)chirurgie
    • Mr.  Prof.Dr.med.  Julian  Mall 
    • Haltenhoffstr. 41
    • 30167  Hannover
    • Germany
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    end of 1:1-Block address contact materialSupport
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    • Medizinische Hochschule Hannover (MHH)Zentrum Innere MedizinKlinik für Gastroenterologie, Hepatologie und Endokrinologie
    • Mr.  Prof.Dr.med.  Michael  Manns 
    • Carl-Neuberg-Str. 1
    • 30625  Hannover
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.