An interventional study of Intragastric balloon and Lifestyle intervention in Obesity, NASH - Nonalcoholic Steatohepatitis and Obesity, Morbid, sponsored by Johns Hopkins University. Withdrawn. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
The primary objective of this study is to assess efficacy of intragastric balloon for weight loss in obese patients who also concurrently have NASH.
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.
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Exclusion Criteria:
All patients included in the study will undergo an evaluation by a nutritionist and will undergo diet and lifestyle intervention.
Behavioral: Lifestyle intervention
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.
Device: Intragastric balloon · Behavioral: Lifestyle intervention
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
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.
Weight loss
Weight lost as a percentage of baseline total body weight
Time frame: 1 year
Liver fibrosis
Fibrosis stage on ultrasound transient elastography
Time frame: 1 year
Liver panel
Biochemical liver panel
Time frame: 1 year
Lipid panel
Lipid panel via blood level measurement
Time frame: 1 year
Complications
Complications associated with intragastric balloon using severity grading according to the ASGE lexicon
Time frame: 1 year
Glucose
Glucose level will be measured by blood test
Time frame: 1 year
No study locations are listed for this record.
This study is withdrawn, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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