Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

Non Alcoholic Steatohepatitis Clinical Trial

Official title:

Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761370
• Other study ID #: D/05/338
• Status: Completed
• Phase: N/A
• First received: November 1, 2011
• Last updated: January 3, 2013
• Start date: November 2005
• Est. completion date: September 2008

Study information

• Verified date: October 2011
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in liver histology	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.	6 months	No