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

NCT03538236 | Withdrawn DMC FDA Device

• 1 other identifier: IRB00115848
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; NASH - Nonalcoholic Steatohepatitis; Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Weight lost as a percentage of baseline total body weight

  1 year

Secondary Outcomes (5)

• Liver fibrosis

  1 year

• Liver panel

  1 year

• Lipid panel

  1 year

• Complications

  1 year

• Glucose

  1 year

Study Arms (2)

Lifestyle intervention alone

ACTIVE COMPARATOR

All patients included in the study will undergo an evaluation by a nutritionist and will undergo diet and lifestyle intervention.

Behavioral: Lifestyle intervention

Intragastric balloon with lifestyle

EXPERIMENTAL

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

Interventions

Intragastric balloon DEVICE

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

Intragastric balloon with lifestyle

Lifestyle intervention BEHAVIORAL

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.

Intragastric balloon with lifestyle; Lifestyle intervention alone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• ReShape Lifesciences: collaborator

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Vivek Kumbhari, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 29, 2018
• Study Start: March 1, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: March 30, 2021

Record last verified: 2020-11