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Completed

NCT Number: NCT01761370

Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH).

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Key information

Conditions

Non Alcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 119074

About this study

The Bio-enteric Intra-gastric balloon (BIB) has been shown to be an effective treatment for weight reduction in obese patients. This study will determine the feasibility of using BIB in the treatment of patients with Non alcoholic Steatohepatitis (NASH). It will evaluate the efficacy of the BIB in improving histology of NASH in obese patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients between 21-65 years of age,
  • Had histological evidence of NASH,
  • Had a BMI of greater than 27kg/m2, and
  • Had failed at least 6 month trial of medical therapy for weight reduction.

Exclusion criteria

  • Patients with any organic disease of the upper GI tract,
  • Were receiving anti-inflammatory drugs,
  • Anticoagulants or steroids, or
  • Had a history of alcoholism or drug addiction. A hiatus hernia of > 5 cm, an active gastric or duodenal ulcer, and prior or intestinal surgery were considered contraindications to the placement of BIB.

Treatment and study plan

AHA diet plus exercise with BIB placement

Procedure

AHA diet plus exercise with BIB placement for 6 months

AHA diet plus exercise with sham BIB placement

Procedure

AHA diet plus exercise with sham BIB placement

Primary outcomes

  1. Change in liver histology

    Time frame: 6 months

    The primary outcome measure was liver histology before and after treatment. Assessment of disease activity was done with the use of the NAS, which grades steatosis, lobular inflammation and hepatocellular ballooning.

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jan 4, 2013
Registry last updated
Jan 4, 2013

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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