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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03538236
• Other study ID #: IRB00115848
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: May 30, 2022

Study information

• Verified date: November 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• NASH - Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease
• Obesity
• Obesity, Morbid

Intervention

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

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	ReShape Lifesciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Weight lost as a percentage of baseline total body weight	1 year
Secondary	Liver fibrosis	Fibrosis stage on ultrasound transient elastography	1 year
Secondary	Liver panel	Biochemical liver panel	1 year
Secondary	Lipid panel	Lipid panel via blood level measurement	1 year
Secondary	Complications	Complications associated with intragastric balloon using severity grading according to the ASGE lexicon	1 year
Secondary	Glucose	Glucose level will be measured by blood test	1 year