ObesityNCT03538236
Intragastric Balloon With Lifestyle Intervention vs. Lifestyle Intervention in Obese Patients With NASH
A study testing Intragastric balloon and Lifestyle intervention in people with Obesity and NASH - Nonalcoholic Steatohepatitis, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obesity, NASH - Nonalcoholic Steatohepatitis, Obesity, Morbid
- What is being tested?
- Intragastric balloon and Lifestyle intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
About this study
Official title: Intragastric Balloon in Combination With Lifestyle Intervention vs. Lifestyle Intervention Alone in Obese Patients Having NASH With Significant Fibrosis
The primary objective of this study is to assess efficacy of intragastric balloon for weight loss in obese patients who also concurrently have NASH.
Read the 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.
- Being tested
- Intragastric balloon, Lifestyle intervention
- Medical subject headings
- Obesity, Non-alcoholic Fatty Liver Disease, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intragastric balloonDevice
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
Lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Intragastric balloon; Behavioral: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight lost as a percentage of baseline total body weight
Measured: 1 year
Secondary outcomes (5)
Liver fibrosis
Fibrosis stage on ultrasound transient elastography
Measured: 1 year
Liver panel
Biochemical liver panel
Measured: 1 year
Lipid panel
Lipid panel via blood level measurement
Measured: 1 year
Complications
Complications associated with intragastric balloon using severity grading according to the ASGE lexicon
Measured: 1 year
Glucose
Glucose level will be measured by blood test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Mar 2021 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Why it stopped: The study did not recruit any patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- ReShape Lifesciences
- Responsible party
- Sponsor
- Investigators
- Vivek Kumbhari, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538236
- Sponsor's protocol ID
- IRB00115848
- Status last verified
- Nov 2020
- First submitted
- 3 May 2018
- Last updated
- 30 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intragastric Balloon in Combination With Lifestyle Intervention vs. Lifestyle Intervention Alone in Obese Patients Having NASH With Significant Fibrosis
- ClinicalTrials.gov ID
- NCT03538236
- Acronym / sponsor ID
- IRB00115848
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not recruit any patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- ReShape Lifesciences
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention alone | Active comparator | Behavioral: Lifestyle interventionAll patients included in the study will undergo an evaluation by a nutritionist and will undergo diet and lifestyle intervention. |
| Intragastric balloon with lifestyle | Experimental | Device: Intragastric balloon, Behavioral: Lifestyle interventionPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intragastric balloonIntragastric 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 | Device | Intragastric balloon with lifestyle |
| Lifestyle interventionAll 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. | Behavioural | Intragastric balloon with lifestyle, Lifestyle intervention alone |
Primary outcome
Weight loss
Time frame: 1 year
Weight lost as a percentage of baseline total body weight
5 secondary outcomes
Liver fibrosis
Time frame: 1 year
Liver panel
Time frame: 1 year
Lipid panel
Time frame: 1 year
Complications
Time frame: 1 year
Glucose
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Kumbhari, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Intragastric balloon and Lifestyle intervention in people with Obesity and NASH - Nonalcoholic Steatohepatitis, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2021.