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Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

Primary Purpose

Non Alcoholic Steatohepatitis

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
AHA diet plus exercise with BIB placement
AHA diet plus exercise with sham BIB placement
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Alcoholic Steatohepatitis focused on measuring Non alcoholic Steatohepatitis, Intra-gastric balloon

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Treatment

Sham control

Arm Description

AHA diet plus exercise with BIB placement

AHA diet plus exercise with sham BIB placement

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 1, 2011
Last Updated
January 3, 2013
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT01761370
Brief Title
Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
Official Title
Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Alcoholic Steatohepatitis
Keywords
Non alcoholic Steatohepatitis, Intra-gastric balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
AHA diet plus exercise with BIB placement
Arm Title
Sham control
Arm Type
Sham Comparator
Arm Description
AHA diet plus exercise with sham BIB placement
Intervention Type
Procedure
Intervention Name(s)
AHA diet plus exercise with BIB placement
Intervention Description
AHA diet plus exercise with BIB placement for 6 months
Intervention Type
Procedure
Intervention Name(s)
AHA diet plus exercise with sham BIB placement
Intervention Description
AHA diet plus exercise with sham BIB placement
Primary Outcome Measure Information:
Title
Change in liver histology
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin Mei Lee, MBChB
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

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Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

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