Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

Not Applicable

Completed

• Conditions: Non Alcoholic Steatohepatitis
• Interventions: Procedure: AHA diet plus exercise with BIB placement; Procedure: AHA diet plus exercise with sham BIB placement

• Registration Number: NCT01761370
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2005-11
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2011-10
• Study First Submitted: 2011-11-01
• Study First Submitted QC: 2013-01-03
• Last Update Submitted: 2013-01-03
• Study First Posted: 2013-01-04
• Last Update Posted: 2013-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	AHA diet plus exercise with BIB placement	AHA diet plus exercise with BIB placement
Sham control	AHA diet plus exercise with sham BIB placement	AHA diet plus exercise with sham BIB placement

Primary Outcome Measures

Name	Time	Method
Change in liver histology	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.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore