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Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01761370
First received: November 1, 2011
Last updated: January 3, 2013
Last verified: October 2011
History of Changes
  Purpose

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


Condition Intervention
Non Alcoholic Steatohepatitis
 Procedure: AHA diet plus exercise with BIB placement
Procedure: AHA diet plus exercise with sham BIB placement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Change in liver histology [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: November 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment
AHA diet plus exercise with BIB placement
 Procedure: AHA diet plus exercise with BIB placement
AHA diet plus exercise with BIB placement for 6 months
Sham Comparator: Sham control
AHA diet plus exercise with sham BIB placement
 Procedure: AHA diet plus exercise with sham BIB placement
AHA diet plus exercise with sham BIB placement

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761370

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Yin Mei Lee, MBChB National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01761370     History of Changes
Other Study ID Numbers: D/05/338
Study First Received: November 1, 2011
Last Updated: January 3, 2013
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Non alcoholic Steatohepatitis
Intra-gastric balloon

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013