Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
NCT ID: NCT01761370
Last Updated: 2013-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2005-11-30
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment
AHA diet plus exercise with BIB placement
AHA diet plus exercise with BIB placement
AHA diet plus exercise with BIB placement for 6 months
Sham control
AHA diet plus exercise with sham BIB placement
AHA diet plus exercise with sham BIB placement
AHA diet plus exercise with sham BIB placement
Interventions
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AHA diet plus exercise with BIB placement
AHA diet plus exercise with BIB placement for 6 months
AHA diet plus exercise with sham BIB placement
AHA diet plus exercise with sham BIB placement
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
65 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Yin Mei Lee, MBChB
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital
Singapore, , Singapore
Countries
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Other Identifiers
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D/05/338
Identifier Type: -
Identifier Source: org_study_id
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