Non Alcoholic Steatohepatitis Clinical Trial
— BRAVESOfficial title:
A Randomized Controlled Study on the Effects of Roux-en-Y Gastric Bypass Versus Sleeve Gastrectomy or Intensive Lifestyle Modifications on Non Alcoholic Steato-Hepatitis
NCT number | NCT03524365 |
Other study ID # | 20182004 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 6, 2018 |
Est. completion date | July 20, 2022 |
Verified date | February 2023 |
Source | Catholic University of the Sacred Heart |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bariatric-metabolic surgery is effective in treating the cluster of conditions forming the metabolic syndrome, strictly associated with NAFLD and NASH. Recently, we and other authors have shown also in the long term (up 5 years) with randomized-controlled trials (RCTs) that bariatric-metabolic surgery allows remission of type 2 diabetes and obesity reduction, which are the two major pathogenetic factors of NASH development, with maintenance of weight loss. Few small and mainly retrospective studies have shown that bariatric surgery is effective in improving NASH histologic picture in obese subjects. The aim of our proposal is to conduct a 3 arm single centre, superiority, RCT comparing Roux-en-Y Gastric Bypass (RYGB) with Sleeve Gastrectomy (SG) and with Intensive Lifestyle Modifications (ILM) for the treatment of Non-Alcoholic Steato-Hepatitis.
Status | Completed |
Enrollment | 288 |
Est. completion date | July 20, 2022 |
Est. primary completion date | July 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 70 Years |
Eligibility | Inclusion Criteria: - Subjects with NASH documented by liver biopsy and no evidence of another form of liver disease with a BMI = 30 and =55 kg/m2. Subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls for the discovery of non-invasive biomarkers. Exclusion Criteria: - Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 6 months; Liver cirrhosis; End stage renal failure; Participation in any other concurrent therapeutic clinical trial; Any other life-threatening, non-cardiac disease; Pregnancy; Inability to give informed consent; Substantial alcohol consumption (>20 g/day for women or >30 g/day for men); Wilson's disease;hepatitis B virus, hepatitis C virus (negative Hepatitis C RNA since more than 3 years will be considered eligible), autoimmune hepatitis, primary biliary cholangitis, haemochromatosis and a-1-antitrypsin deficiency; Lipodystrophy; Parenteral nutrition; Abetalipoproteinemia; Interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids). |
Country | Name | City | State |
---|---|---|---|
Italy | San Camillo | Roma | |
Italy | University of Rome Sapienza | Roma | |
Italy | Catholic University School of Medicine | Rome |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart | University of Roma La Sapienza |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | histological resolution of NASH without worsening of fibrosis at 1 year after the interventions | Histological diagnosis of NASH is established according to widely accepted criteria, using the NAFLD activity score (NAS) algorithm proposed by the NASH Clinical Research Network (CRN). These criteria include presence of steatosis in >5% of hepatocytes, hepatocellular ballooning and lobular inflammatory infiltrates. The presence and stages of fibrosis will be also assessed using the NASH-CRN system: stage 0 =no fibrosis; stage 1 =centrilobular pericellular fibrosis; stage 2 =centrilobular and periportal fibrosis; stage 3 =bridging fibrosis; and stage 4 =cirrhosis. | 1 year | |
Secondary | Adverse health events including the need for re-operation | adverse events include early operation complications | 1 year | |
Secondary | Improvement of at least 1 point of histological liver fibrosis without worsening of NASH | liver fibrosis will be examined in liver biopsies | 1 year | |
Secondary | Changes in glycemic control (only in diabetic patients) | diabetes remission or improvement of glycemic control (glycated hemoglobin HbA1c) | 1 year | |
Secondary | Changes in insulin sensitivity | HOMA IR or oral glucose minimal model | 1 year | |
Secondary | Changes in food intake | food intake diary | 1 year | |
Secondary | Changes in physical activity | Physical activity questionnaire | 1 year | |
Secondary | Changes in body composition: Fat-Free Mass (FFM), Fat Mass (FM). | FFM and FM will be assessed by DEXA | 1 year |
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