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Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT01761370
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

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

Condition or disease Intervention/treatment Phase
Non Alcoholic Steatohepatitis Procedure: AHA diet plus exercise with BIB placement Procedure: AHA diet plus exercise with sham BIB placement Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
Study Start Date : November 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008


Arm Intervention/treatment
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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): 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

Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01761370     History of Changes
Other Study ID Numbers: D/05/338
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: January 4, 2013
Last Verified: October 2011

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

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases