Liver CirrhosisNCT03753438
Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics
An observational study of Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The study will be conducted in department of Hepatology at ILBS, the patients will be recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for standard of care and also patients who undergo IGB placement as part of weight reduction policy in these group of patients and will undergo… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Intragstric Ballooning
- Type of treatment
- Surgery or procedure
- How many people
- 56 participants
- Where
- 1 siteIndia
- Study dates
- 2 Aug 2016to 31 May 2020
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NASH (Non Alcoholic SteatoHepatitis) cirrhosis.
Who may be able to join
- Adult patients between 18 and 65 years
- NASH (Non Alcoholic SteatoHepatitis) cirrhosis
- BMI > 30 and failure to control weight despite full dietary and life style modifications.
- Compensated : CTP 6 \& 7 without any evidence of decompensation in form of Hepatic encephalopathy, ascites, GI bleed or prolonged jaundice.
- Small varices: Grade I varices
Who cannot join
- Alcoholic liver disease
- Advanced liver disease with ascites, hepatic encephalopathy
- Other liver diseases such as chronic hepatitis B, chronic hepatitis C, Wilsons' disease, Hemochromatosis, glycogen storage diseases etc.
- Pregnancy
- Unwilling patients
- Large varices
Show all 11Show fewer
- Past h/o GI bleed
- Hiatus hernia
- Gastric ulcer
- Severe esophagitis (Grade B and above)
- Severe PHG or gastric erythema
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics-An Observational Study
The study will be conducted in department of Hepatology at ILBS, the patients will be recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for standard of care and also patients who undergo IGB placement as part of weight reduction policy in these group of patients and will undergo an UGI endoscopy followed by placement of intragastric balloon. Then the patients will be admitted for 2-3 days and followed up till 6 months.
- Conditions
- Liver Cirrhosis
- Being tested
- Intragstric Ballooning
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intragstric BallooningProcedure or surgery
Intragstric Ballooning will be put.
| Study group | Role | What they receive |
|---|---|---|
| Intragastric Balloon | Intragastric Balloon will be placed for 6 months Receives: Procedure: Intragstric Ballooning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight from baseline
Measured: 3 months
Change in weight reduction from baseline
Measured: 6 Months
Secondary outcomes (32)
Change in development of liver related complications
Measured: 3 Months
Change in development of liver related complications
Measured: 6 Months
Improvement of insulin resistance in both groups.
Measured: 3 Months
Improvement of insulin resistance in both groups.
Measured: 6 Months
Decreased usage of medications for diabetes mellitus in both groups.
Measured: 3 Months
Decreased usage of medications for diabetes mellitus in both groups.
Measured: 6 Months
Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.
Measured: 3 Months
Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.
Measured: 6 Months
Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).
Measured: 3 Months
Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).
Measured: 6 Months
Improvement in liver parameters such as serum albumin in both groups.
Measured: 3 Months
Improvement in liver parameters such as serum albumin in both groups.
Measured: 6 Months
Improvement liver parameters such as INR in both groups
Measured: 3 Months
Improvement in liver parameters such as INR in both groups.
Measured: 6 Months
Improvement in liver parameters such as bilirubin in both groups
Measured: 3 Months
Improvement in liver parameters such as bilirubin in both groups.
Measured: 6 Months
Disappearance of esophageal varices in both groups.
Measured: 3 Months
Disappearance of esophageal varices in both groups.
Measured: 6 Months
Improvement in LSM (liver stiffness on fibroscan) in both groups
Measured: 3 Months
Improvement in LSM (liver stiffness on fibroscan) in both groups.
Measured: 6 Months
Improvement in CAP (Controlled Attenuation Index) in both groups.
Measured: 3 Months
Improvement in CAP (Controlled Attenuation Index) in both groups.
Measured: 6 Months
Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.
Measured: 3 Months
Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.
Measured: 6 Months
Improvement in liver histology post completion of study in both groups.
Measured: 6 Months
Change in hormonal levels such as Adiponectin level in both groups..
Measured: 3 Months
Change in hormonal levels such as Adiponectin level in both groups.
Measured: 6 months
Change in hormonal levels such as leptin level in both groups.
Measured: 3 Months
Change in hormonal levels such as Ghrelin level in both groups..
Measured: 3 Months
Change in hormonal levels such as Ghrelin level in both groups..
Measured: 6 Months
Change in hormonal levels such as Endothelin level in both groups..
Measured: 3 Month
Change in hormonal levels such as Endothelin level in both groups..
Measured: 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start2 Aug 2016
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shiv Kumar Sarin, DM, Principal investigator, Institute of Liver & Biliary Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753438
- Sponsor's protocol ID
- ILBS-NASH-04
- Status last verified
- Jun 2021
- First submitted
- 17 Oct 2018
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vijayaraghavan R, Sarin SK, Bharadwaj A, Anand L, Maiwall R, Choudhury A, Benjamin J, Kanal U, Jamwal KD. Intragastric Balloon in Obese Compensated Nonalcoholic Steatohepatitis Cirrhosis Patients Is Safe and Achieves Significant Weight Reduction at 6-Months. Dig Dis Sci. 2023 Mar;68(3):1035-1041. doi: 10.1007/s10620-022-07596-4. Epub 2022 Jun 28.
PubMed 35763235
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics-An Observational Study
- ClinicalTrials.gov ID
- NCT03753438
- Acronym / sponsor ID
- ILBS-NASH-04
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 2 Aug 2016 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 27 Nov 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 study will be conducted in department of Hepatology at ILBS, the patients will be recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for standard of care and also patients who undergo IGB placement as part of weight reduction policy in these group of patients and will undergo an UGI endoscopy followed by placement of intragastric balloon. Then the patients will be admitted for 2-3 days and followed up till 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intragastric Balloon | – | Procedure: Intragstric BallooningIntragastric Balloon will be placed for 6 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NASH (Non Alcoholic SteatoHepatitis) cirrhosis.
Key inclusion criteria (5 listed)
- Adult patients between 18 and 65 years
- NASH (Non Alcoholic SteatoHepatitis) cirrhosis
- BMI > 30 and failure to control weight despite full dietary and life style modifications.
- Compensated : CTP 6 \& 7 without any evidence of decompensation in form of Hepatic encephalopathy, ascites, GI bleed or prolonged jaundice.
- Small varices: Grade I varices
Key exclusion criteria (11 listed)
- Alcoholic liver disease
- Advanced liver disease with ascites, hepatic encephalopathy
- Other liver diseases such as chronic hepatitis B, chronic hepatitis C, Wilsons' disease, Hemochromatosis, glycogen storage diseases etc.
- Pregnancy
- Unwilling patients
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 |
|---|---|---|
| Intragstric BallooningIntragstric Ballooning will be put. | Procedure or surgery | Intragastric Balloon |
Primary outcome
Change in weight from baseline
Time frame: 3 months
Change in weight reduction from baseline
Time frame: 6 Months
32 secondary outcomes
Change in development of liver related complications
Time frame: 3 Months
Change in development of liver related complications
Time frame: 6 Months
Improvement of insulin resistance in both groups.
Time frame: 3 Months
Improvement of insulin resistance in both groups.
Time frame: 6 Months
Decreased usage of medications for diabetes mellitus in both groups.
Time frame: 3 Months
Decreased usage of medications for diabetes mellitus in both groups.
Time frame: 6 Months
Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.
Time frame: 3 Months
Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.
Time frame: 6 Months
Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).
Time frame: 3 Months
Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).
Time frame: 6 Months
Improvement in liver parameters such as serum albumin in both groups.
Time frame: 3 Months
Improvement in liver parameters such as serum albumin in both groups.
Time frame: 6 Months
Improvement liver parameters such as INR in both groups
Time frame: 3 Months
Improvement in liver parameters such as INR in both groups.
Time frame: 6 Months
Improvement in liver parameters such as bilirubin in both groups
Time frame: 3 Months
Improvement in liver parameters such as bilirubin in both groups.
Time frame: 6 Months
Disappearance of esophageal varices in both groups.
Time frame: 3 Months
Disappearance of esophageal varices in both groups.
Time frame: 6 Months
Improvement in LSM (liver stiffness on fibroscan) in both groups
Time frame: 3 Months
Improvement in LSM (liver stiffness on fibroscan) in both groups.
Time frame: 6 Months
Improvement in CAP (Controlled Attenuation Index) in both groups.
Time frame: 3 Months
Improvement in CAP (Controlled Attenuation Index) in both groups.
Time frame: 6 Months
Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.
Time frame: 3 Months
Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.
Time frame: 6 Months
Improvement in liver histology post completion of study in both groups.
Time frame: 6 Months
Change in hormonal levels such as Adiponectin level in both groups..
Time frame: 3 Months
Change in hormonal levels such as Adiponectin level in both groups.
Time frame: 6 months
Change in hormonal levels such as leptin level in both groups.
Time frame: 3 Months
Change in hormonal levels such as Ghrelin level in both groups..
Time frame: 3 Months
Change in hormonal levels such as Ghrelin level in both groups..
Time frame: 6 Months
Change in hormonal levels such as Endothelin level in both groups..
Time frame: 3 Month
Change in hormonal levels such as Endothelin level in both groups..
Time frame: 6 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Derived from this study: PubMed 35763235Vijayaraghavan R, Sarin SK, Bharadwaj A, Anand L, Maiwall R, Choudhury A, Benjamin J, Kanal U, Jamwal KD. Intragastric Balloon in Obese Compensated Nonalcoholic Steatohepatitis Cirrhosis Patients Is Safe and Achieves Significant Weight Reduction at 6-Months. Dig Dis Sci. 2023 Mar;68(3):1035-1041. doi: 10.1007/s10620-022-07596-4. Epub 2022 Jun 28.
- Individual participant dataSharing planned: Undecided
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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.
Shiv Kumar Sarin, DM principal investigator
Institute of Liver & Biliary Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 5 inclusion and 11 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: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in weight from baseline (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753438, which also lists 1 linked publication.
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 23 Jun 2021.