Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)

National University Hospital, Singapore21 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Non Alcoholic Steatohepatitis

Interventions

AHA diet plus exercise with BIB placementPROCEDURE

AHA diet plus exercise with BIB placement for 6 months

AHA diet plus exercise with sham BIB placementPROCEDURE

AHA diet plus exercise with sham BIB placement

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

National University Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

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.

Time frame: 6 months

Data from ClinicalTrials.gov

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