Effect of Adjustable Intragastric Balloon in Obese Non-alcoholic Fatty Liver Disease

Obesity Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

Aims and objectives:

The Investigator aimed to evaluate effect of adjustable intra gastric balloon on non-alcoholic fatty liver disease/non alcoholic steatohepatitis (NAFLD/NASH) with or without diabetes mellitus, who have failed to achieve >10% of total body weight with lifestyle interventions and pharmacotherapy for weight loss.

The Investigator will evaluate NASH parameters such as NASH activity score(NAS), liver function tests along with weight loss and change in glycaemic control and changes in hormonal activity.

Sample size:

Based on previous study, to achieve median reduction of 40% in NAS score with 80% power and 0.05 as type 1 error; total sample size required is 36 cases.

Clinical Trial Description

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.

Follow-up:

At the 3rd month visit, participants would be re motivated and re-explained the weight loss importance and the lifestyle and dietary changes for resolution of NAFLD/ NASH. At this stage, they would be introduced the concept of endoscopic intragastric balloon as a prospective treatment as a part of the clinical study.

At the 6-month visit, if the participants has failed to lose at least 7% weight despite adequate exercise and lifestyle and dietary changes, then they would be offered to be enrolled in this clinical study. Alternative therapies including bariatric surgery and continuing with life style modifications and medications would be explained.

Method of Balloon Insertion and Post Procedure Care:

All participants will undergo upper gastrointestinal endoscopy using conscious sedation with or without an anaesthetist using one or more of the following medications - Propofol or midazolam.

The Spatz balloons are usually inflated with a mean 450ml (400-500ml) of normal saline with the addition of 2-3 ml of a 1% solution of Methylene Blue. After the 5th post-procedure day, a progressive full liquid to soft solid 1,200-1,400 kcal diet will be started. At one month follow up with principal investigator will be done. Participants who are intolerant to the balloon could be adjusted downward by 50-100 ml. Participants with one or more of the following were offered upward adjustments of the balloon volume (100-200 ml at the discretion of the endoscopist): weight loss plateau; lack of balloon effect; ability to overeat without resultant symptoms (any of the following: nausea, vomiting, bloating, eructation, abdominal pain, acid reflux symptoms). After 12 months of placement, the balloon will be deflated by aspiration via catheter and then retrieved under endoscopic/fluoroscopic guidance.

The data will be collected in excel sheets and later analysed using statistical analysis software. Any adverse effects would be noted and any serious adverse effects like severe pain, severe diarrhoea or catheter impaction which has been reported in less than 1% participants would be reported and adequate measures will be taken. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-Alcoholic Steatohepatitis
• Obesity

• NCT number: NCT04182646
• Study type: Interventional
• Source: Asian Institute of Gastroenterology, India
• Contact: Rakesh Kalapala, DNB
• Phone: 040 4244 4222
• Email: drrakesh.kalapala@aighospitals.com
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2020
• Completion date: December 31, 2020