A Clinical Study on the Effect of Adjustable Intragastric Balloon in Obese Patients With Non Alcoholic Fatty Liver Disease(NAFLD) or Non-Alcoholic Steatohepatitis (NASH) With or Without Diabetes Mellitus

Introduction:

Nonalcoholic fatty liver disease (NAFLD) is an emerging major health problem worldwide which affects a significant proportion of the western population and there is gradual spread of this epidemic to south-east Asian countries. NAFLD encompasses two entities: Non-alcoholic fatty liver (NAFL) and Non-alcoholic steatohepatitis (NASH). NAFL is defined as the evidence of hepatic steatosis without inflammation either by raised liver enzymes, imaging or by histology in individuals without significant alcohol consumption in whom secondary causes of steatosis are absent. NASH on the other hand, is characterized by the presence of both steatosis and inflammation with evidence of hepatocyte injury in the form of ballooning with or without fibrosis.

Materials and Methods:

Study Enrollment:

Participants with diabetes attending the liver and bariatric clinic of the institute who have a Body Mass Index (BMI) > 27.5 Kg/m2 would be screened for eligibility. At first diagnosis of NAFLD / NASH, participants would be advised as per protocol to first attend the department of dietetic and nutrition for a low calorie diet and would also be advised for life style modifications for the next 6 months. They would be explained that the target weight loss would be 10% of the base weight. The exercise program would include a combination of aerobic, resistive and core building exercises. The participants would also be screened for secondary causes of obesity like hypothyroidism, hypercortisolism etc. Co morbidities like hypertension, hypothyroidism etc. would be screened and treated accordingly as per protocol. Secondary causes of NAFLD/ NASH would be ruled out by adequate history of intake of any steatogenic drugs as well as ruling out other conditions like Wilson disease, Autoimmune hepatitis, Viral hepatitis etc. Baseline investigations would include complete hemogram , liver function tests, anti-nuclear antibodies, anti-smooth muscle antibodies, anti-liver-kidney-microsomal antibodies, serum copper, serum ceruloplasmin, thyroid stimulating hormone , 8 am serum cortisol, fasting insulin, hepatitis B surface antigen and anti-hepatitis C antibody screening. Additional tests would include renal function tests, gut hormones assessment, electrocardiography, ultrasonography of the abdomen with acoustic resonance fibrosis imaging (ARFI) or a fibro scan. Additional tests like CT abdomen or high density proton fraction estimation by Magnetic resonance imaging would be done wherever clinically indicated. A liver biopsy would be advised to assess the presence of NASH and grading of fibrosis would be done by the interventional radiologist and reported by expert pathologist.