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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03753438
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief 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 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.

Condition or disease Intervention/treatment
Liver Cirrhosis Procedure: Intragstric Ballooning Dietary Supplement: Standard of Care

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Study Type : Observational
Estimated Enrollment : 96 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics-An Observational Study
Actual Study Start Date : March 1, 2016
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020


Group/Cohort Intervention/treatment
Intragastric Balloon
Intragastric Balloon will be placed for 6 months
Procedure: Intragstric Ballooning
Intragstric Ballooning will be put.

Standard of Care
Patients in this group will be standard of care
Dietary Supplement: Standard of Care
Standard of Care




Primary Outcome Measures :
  1. Change in weight from baseline [ Time Frame: 3 months ]
  2. Change in weight reduction from baseline [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Change in development of liver related complications [ Time Frame: 3 Months ]
  2. Change in development of liver related complications [ Time Frame: 6 Months ]
  3. Improvement of insulin resistance in both groups. [ Time Frame: 3 Months ]
  4. Improvement of insulin resistance in both groups. [ Time Frame: 6 Months ]
  5. Decreased usage of medications for diabetes mellitus in both groups. [ Time Frame: 3 Months ]
  6. Decreased usage of medications for diabetes mellitus in both groups. [ Time Frame: 6 Months ]
  7. Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups. [ Time Frame: 3 Months ]
  8. Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups. [ Time Frame: 6 Months ]
  9. Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha). [ Time Frame: 3 Months ]
  10. Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha). [ Time Frame: 6 Months ]
  11. Improvement in liver parameters such as serum albumin in both groups. [ Time Frame: 3 Months ]
  12. Improvement in liver parameters such as serum albumin in both groups. [ Time Frame: 6 Months ]
  13. Improvement liver parameters such as INR in both groups [ Time Frame: 3 Months ]
  14. Improvement in liver parameters such as INR in both groups. [ Time Frame: 6 Months ]
  15. Improvement in liver parameters such as bilirubin in both groups [ Time Frame: 3 Months ]
  16. Improvement in liver parameters such as bilirubin in both groups. [ Time Frame: 6 Months ]
  17. Disappearance of esophageal varices in both groups. [ Time Frame: 3 Months ]
  18. Disappearance of esophageal varices in both groups. [ Time Frame: 6 Months ]
  19. Improvement in LSM (liver stiffness on fibroscan) in both groups [ Time Frame: 3 Months ]
  20. Improvement in LSM (liver stiffness on fibroscan) in both groups. [ Time Frame: 6 Months ]
  21. Improvement in CAP (Controlled Attenuation Index) in both groups. [ Time Frame: 3 Months ]
  22. Improvement in CAP (Controlled Attenuation Index) in both groups. [ Time Frame: 6 Months ]
  23. Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups. [ Time Frame: 3 Months ]
  24. Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups. [ Time Frame: 6 Months ]
  25. Improvement in liver histology post completion of study in both groups. [ Time Frame: 6 Months ]
  26. Change in hormonal levels such as Adiponectin level in both groups.. [ Time Frame: 3 Months ]
  27. Change in hormonal levels such as Adiponectin level in both groups. [ Time Frame: 6 months ]
  28. Change in hormonal levels such as leptin level in both groups. [ Time Frame: 3 Months ]
  29. Change in hormonal levels such as Ghrelin level in both groups.. [ Time Frame: 3 Months ]
  30. Change in hormonal levels such as Ghrelin level in both groups.. [ Time Frame: 6 Months ]
  31. Change in hormonal levels such as Endothelin level in both groups.. [ Time Frame: 3 Month ]
  32. Change in hormonal levels such as Endothelin level in both groups.. [ Time Frame: 6 Month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
NASH (Non Alcoholic SteatoHepatitis) cirrhosis.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03753438


Contacts
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Contact: Dr V Rajan, DM 01146300000 rajanvf40@gmail.com
Contact: Dr Ankit Bhardwaj, PGDCR bhardwaj.ankit3@gmail.com

Locations
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India
Institute of Liver & Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Dr V Rajan, DM    01146300000    rajanvf40@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Shiv Kumar Sarin, DM Institute of Liver & Biliary Sciences
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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03753438    
Other Study ID Numbers: ILBS-NASH-04
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases