Clinical trial NCT03538236: Intragastric Balloon With Lifestyle Intervention vs. Lifestyle Intervention in Obese Patients With NASH
Official title: Intragastric Balloon in Combination With Lifestyle Intervention vs. Lifestyle Intervention Alone in Obese Patients Having NASH With Significant Fibrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
NASH - Nonalcoholic Steatohepatitis
Obesity, Morbid
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: ReShape Lifesciences
First posted: 2018-05-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss
timeFrame: 1 year
Secondary outcomes:
measure: Liver fibrosis
timeFrame: 1 year
measure: Liver panel
timeFrame: 1 year
measure: Lipid panel
timeFrame: 1 year
measure: Complications
timeFrame: 1 year
measure: Glucose
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Vivek Kumbhari, MD
role: PRINCIPAL_INVESTIGATOR
References: