NCT03538236

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Obesity
• NASH - Nonalcoholic Steatohepatitis
• Obesity, Morbid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2018-05-29
• Last updated: 2021-03-30

Regulatory

• FDA-regulated device study