Non Alcoholic SteatohepatitisNCT01761370
Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
A study testing AHA diet plus exercise with BIB placement in people with Non Alcoholic Steatohepatitis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Non Alcoholic Steatohepatitis
- What is being tested?
- AHA diet plus exercise with BIB placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteSingapore
- Study dates
- Nov 2005to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The study will determine the feasibility of using Bioenteric intragastric balloon (BIB) in the treatment of patients with Non alcoholic Steatohepatitis (NASH).
Read the 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.
- Conditions
- Non Alcoholic Steatohepatitis
- Being tested
- AHA diet plus exercise with BIB placement, AHA diet plus exercise with sham BIB placement
- Keywords
- Non alcoholic Steatohepatitis, Intra-gastric balloon
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AHA diet plus exercise with BIB placementProcedure or surgery
AHA diet plus exercise with BIB placement for 6 months
AHA diet plus exercise with sham BIB placementProcedure or surgery
AHA diet plus exercise with sham BIB placement
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | AHA diet plus exercise with BIB placement Receives: Procedure: AHA diet plus exercise with BIB placement |
| Sham control | Sham comparator | AHA diet plus exercise with sham BIB placement Receives: Procedure: AHA diet plus exercise with sham BIB placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startNov 2005
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yin Mei Lee, MBChB, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761370
- Sponsor's protocol ID
- D/05/338
- Status last verified
- Oct 2011
- First submitted
- 1 Nov 2011
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT01761370
- Acronym / sponsor ID
- D/05/338
- Conditions
- Non Alcoholic Steatohepatitis
- Keywords
- Non alcoholic Steatohepatitis, Intra-gastric balloon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Procedure: AHA diet plus exercise with BIB placementAHA diet plus exercise with BIB placement |
| Sham control | Sham comparator | Procedure: AHA diet plus exercise with sham BIB placementAHA diet plus exercise with sham BIB placement |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AHA diet plus exercise with BIB placementAHA diet plus exercise with BIB placement for 6 months | Procedure or surgery | Treatment |
| AHA diet plus exercise with sham BIB placementAHA diet plus exercise with sham BIB placement | Procedure or surgery | Sham control |
Primary outcome
Change in liver histology
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin Mei Lee, MBChB principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AHA diet plus exercise with BIB placement in people with Non Alcoholic Steatohepatitis, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver histology (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2013.