search
Back to results

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

Primary Purpose

Obesity, NASH - Nonalcoholic Steatohepatitis, Obesity, Morbid

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intragastric balloon
Lifestyle intervention
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Lifestyle intervention alone

    Intragastric balloon with lifestyle

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Weight loss
    Weight lost as a percentage of baseline total body weight

    Secondary Outcome Measures

    Liver fibrosis
    Fibrosis stage on ultrasound transient elastography
    Liver panel
    Biochemical liver panel
    Lipid panel
    Lipid panel via blood level measurement
    Complications
    Complications associated with intragastric balloon using severity grading according to the ASGE lexicon
    Glucose
    Glucose level will be measured by blood test

    Full Information

    First Posted
    May 3, 2018
    Last Updated
    March 25, 2021
    Sponsor
    Johns Hopkins University
    Collaborators
    ReShape Lifesciences
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03538236
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study did not recruit any patients.
    Study Start Date
    March 1, 2021 (Anticipated)
    Primary Completion Date
    May 30, 2022 (Anticipated)
    Study Completion Date
    May 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    ReShape Lifesciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, NASH - Nonalcoholic Steatohepatitis, Obesity, Morbid

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lifestyle intervention alone
    Arm Type
    Active Comparator
    Arm Description
    All patients included in the study will undergo an evaluation by a nutritionist and will undergo diet and lifestyle intervention.
    Arm Title
    Intragastric balloon with lifestyle
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Intragastric balloon
    Intervention Description
    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
    Intervention Type
    Behavioral
    Intervention Name(s)
    Lifestyle intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Weight loss
    Description
    Weight lost as a percentage of baseline total body weight
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Liver fibrosis
    Description
    Fibrosis stage on ultrasound transient elastography
    Time Frame
    1 year
    Title
    Liver panel
    Description
    Biochemical liver panel
    Time Frame
    1 year
    Title
    Lipid panel
    Description
    Lipid panel via blood level measurement
    Time Frame
    1 year
    Title
    Complications
    Description
    Complications associated with intragastric balloon using severity grading according to the ASGE lexicon
    Time Frame
    1 year
    Title
    Glucose
    Description
    Glucose level will be measured by blood test
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vivek Kumbhari, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs