Intragastric Balloon With Lifestyle Intervention vs. Lifestyle Intervention in Obese Patients With NASH

Intragastric Balloon in Combination With Lifestyle Intervention vs. Lifestyle Intervention Alone in Obese Patients Having NASH With Significant Fibrosis

The primary objective of this study is to assess efficacy of intragastric balloon for weight loss in obese patients who also concurrently have NASH.

Study Overview

• Status: Withdrawn
• Conditions: Obesity; Obesity, Morbid; NASH - Nonalcoholic Steatohepatitis
• Intervention / Treatment: Behavioral: Lifestyle intervention; Device: Intragastric balloon

Detailed Description

Non-alcoholic steatohepatitis (NASH) is a growing and leading etiology of chronic liver disease worldwide resulting in substantial morbidity and mortality.

Given recent data confirming weight loss as an effective treatment strategy for NASH and the recent availability of endoscopic bariatric therapies recently described by the American Society for Gastrointestinal Endoscopy (ASGE) and approved by the Food and Drug Administration (FDA), the investigators seek to primarily study efficacy of intragastric balloon for weight loss in obese patients having NASH. Secondary objective would be to assess whether the use of intragastric balloon combined with lifestyle intervention can improve liver histology in NASH with significant fibrosis over lifestyle intervention alone in a prospective paired study.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with BMI 30-35 (obese individuals who qualify for Intragastric Balloon (IGB) as per FDA but who do not qualify for bariatric surgery)
• Patients with NASH defined as presence of steatosis by ultrasound transient elastography with Controlled Attenuation Parameter (CAP) and persistent elevation in liver enzymes without significant history of alcohol consumption (>21 drinks/week in men and >14 drinks/week in women) and with other etiology of chronic liver diseases excluded including medication induced steatosis
• Severe fibrosis F3-F4 on ultrasound elastography

Exclusion Criteria:

• Suspected or biopsy confirmed liver cirrhosis
• Significant ethanol consumption >21 drinks/week in men and >14 drinks/week in women
• Patients with human immunodeficiency virus (HIV)
• Patients on medications associated with steatohepatitis including amiodarone, diltiazem, corticosteroids, methotrexate, tamoxifen, protease inhibitors, and valproate
• Presence of other chronic liver disease including hepatitis B-C, autoimmune hepatitis, alpha 1 antitrypsin deficiency, Wilson's disease, and hemochromatosis
• Pregnant or breast-feeding
• Patients who already have an intragastric balloon
• Patients with Gastroesophageal reflux disease (GERD)
• Patients with previous gastric surgeries, altered gastrointestinal anatomy such as Billroth I, Billroth II, roux-en-y gastrectomy, roux-en-y hepaticojejunostomy, or any restrictive or bypass bariatric surgery
• Presence of inflammatory disorder of the gastrointestinal tract
• Patients with active peptic ulcer disease
• Patients with gastroesophageal varices
• Presence of a large hiatal hernia (grade IV on Hills classification: large hiatal hernia and essentially no fold approximating the endoscope in the retroflexed view and where the lumen of the esophagus is gaping open allowing the squamous epithelium to be seen)
• Structural abnormality in the esophagus or pharynx
• Have major esophageal motility disorders as per the Chicago classification including achalasia, diffuse esophageal spasm, jackhammer esophagus, and Esophagogastric junction (EGJ) outflow obstruction
• Mucosal or submucosal gastric mass that is clinically suspected to be of malignant nature
• Severe clotting or bleeding disorder
• Other medical condition that does not allow for endoscopic procedure
• Severe psychiatric illness
• Unable to participate in routine medical follow-up
• On antiplatelet agents including clopidogrel, ticlopidine, prasugrel, and cangrelor. Aspirin use will be allowed
• On anticoagulants including heparin, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lifestyle intervention alone; All patients included in the study will undergo an evaluation by a nutritionist and will undergo diet and lifestyle intervention.	Behavioral: Lifestyle intervention; All patients included in the study will undergo an evaluation by a nutritionist. All participants will receive recommendations for a diet. Participants will be instructed to keep a daily food diary and will meet with the nutritionist to reinforce the behavior every 12 weeks for 12 months.
Experimental: Intragastric balloon with lifestyle; Patients who do not reach the 10% weight loss with lifestyle intervention alone after 6 months will be offered to have intragastric balloon insertion for 6 months. Regardless of whether an intragastric balloon is inserted, all patients will continue with the same lifestyle changes described above for another 6 months.	Behavioral: Lifestyle intervention; All patients included in the study will undergo an evaluation by a nutritionist. All participants will receive recommendations for a diet. Participants will be instructed to keep a daily food diary and will meet with the nutritionist to reinforce the behavior every 12 weeks for 12 months.; Device: Intragastric balloon; Intragastric balloon insertion will be performed by an endoscopist under monitored anesthesia care. The Intragastric BalIoon (GB) comes as a deflated balloon pre-loaded on a catheter, which is inserted transorally into the proximal gastric body. An endoscope is then inserted alongside the device allowing for direct visualization of the balloon. Once in place, the intragastric balloon will be filled with saline through an external port. The balloon is inserted for 6 months then retrieved endoscopically

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight loss	Weight lost as a percentage of baseline total body weight	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver fibrosis	Fibrosis stage on ultrasound transient elastography	1 year
Liver panel	Biochemical liver panel	1 year
Lipid panel	Lipid panel via blood level measurement	1 year
Complications	Complications associated with intragastric balloon using severity grading according to the ASGE lexicon	1 year
Glucose	Glucose level will be measured by blood test	1 year

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: ReShape Lifesciences

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2021
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: May 3, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Fatty Liver; Non-alcoholic Fatty Liver Disease; Obesity, Morbid
• Other Study ID Numbers: IRB00115848

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes