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Completed

NCT Number: NCT03753438

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

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intragstric Ballooning

Procedure

Intragstric Ballooning will be put.

Primary outcomes

  1. Change in weight from baseline

    Time frame: 3 months

  2. Change in weight reduction from baseline

    Time frame: 6 Months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics-An Observational Study

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 27, 2018
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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