Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics

June 17, 2021 updated by: Institute of Liver and Biliary Sciences, India

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of Liver & Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

NASH (Non Alcoholic SteatoHepatitis) cirrhosis.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Past h/o GI bleed
  • Hiatus hernia
  • Gastric ulcer
  • Severe esophagitis (Grade B and above)
  • Severe PHG or gastric erythema

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Intragastric Balloon
Intragastric Balloon will be placed for 6 months
Procedure: Intragstric Ballooning
Intragstric Ballooning will be put.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in weight from baseline
Time Frame: 3 months
3 months
Change in weight reduction from baseline
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in development of liver related complications
Time Frame: 3 Months
3 Months
Change in development of liver related complications
Time Frame: 6 Months
6 Months
Improvement of insulin resistance in both groups.
Time Frame: 3 Months
3 Months
Improvement of insulin resistance in both groups.
Time Frame: 6 Months
6 Months
Decreased usage of medications for diabetes mellitus in both groups.
Time Frame: 3 Months
3 Months
Decreased usage of medications for diabetes mellitus in both groups.
Time Frame: 6 Months
6 Months
Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.
Time Frame: 3 Months
3 Months
Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.
Time Frame: 6 Months
6 Months
Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).
Time Frame: 3 Months
3 Months
Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).
Time Frame: 6 Months
6 Months
Improvement in liver parameters such as serum albumin in both groups.
Time Frame: 3 Months
3 Months
Improvement in liver parameters such as serum albumin in both groups.
Time Frame: 6 Months
6 Months
Improvement liver parameters such as INR in both groups
Time Frame: 3 Months
3 Months
Improvement in liver parameters such as INR in both groups.
Time Frame: 6 Months
6 Months
Improvement in liver parameters such as bilirubin in both groups
Time Frame: 3 Months
3 Months
Improvement in liver parameters such as bilirubin in both groups.
Time Frame: 6 Months
6 Months
Disappearance of esophageal varices in both groups.
Time Frame: 3 Months
3 Months
Disappearance of esophageal varices in both groups.
Time Frame: 6 Months
6 Months
Improvement in LSM (liver stiffness on fibroscan) in both groups
Time Frame: 3 Months
3 Months
Improvement in LSM (liver stiffness on fibroscan) in both groups.
Time Frame: 6 Months
6 Months
Improvement in CAP (Controlled Attenuation Index) in both groups.
Time Frame: 3 Months
3 Months
Improvement in CAP (Controlled Attenuation Index) in both groups.
Time Frame: 6 Months
6 Months
Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.
Time Frame: 3 Months
3 Months
Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.
Time Frame: 6 Months
6 Months
Improvement in liver histology post completion of study in both groups.
Time Frame: 6 Months
6 Months
Change in hormonal levels such as Adiponectin level in both groups..
Time Frame: 3 Months
3 Months
Change in hormonal levels such as Adiponectin level in both groups.
Time Frame: 6 months
6 months
Change in hormonal levels such as leptin level in both groups.
Time Frame: 3 Months
3 Months
Change in hormonal levels such as Ghrelin level in both groups..
Time Frame: 3 Months
3 Months
Change in hormonal levels such as Ghrelin level in both groups..
Time Frame: 6 Months
6 Months
Change in hormonal levels such as Endothelin level in both groups..
Time Frame: 3 Month
3 Month
Change in hormonal levels such as Endothelin level in both groups..
Time Frame: 6 Month
6 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Liver and Biliary Sciences, India

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shiv Kumar Sarin, DM, Institute of Liver & Biliary Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILBS-NASH-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Cirrhosis

Clinical Trials on Intragstric Ballooning

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings