Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

• Sponsor: National University Hospital, Singapore (Other)
• Overall Status: Completed
• CT.gov ID: NCT01761370
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 34
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Nov 1, 2005
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	National University Hospital	Singapore		Singapore	119074

Sponsors and Collaborators

• National University Hospital, Singapore

Investigators

• Principal Investigator: Yin Mei Lee, MBChB, National University Hospital, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National University Hospital, Singapore
• ClinicalTrials.gov Identifier: NCT01761370
• Other Study ID Numbers: D/05/338
• First Posted: Jan 4, 2013
• Last Update Posted: Jan 4, 2013
• Last Verified: Oct 1, 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

Study Results

No Results Posted as of Jan 4, 2013