NASH - Nonalcoholic SteatohepatitisBeLEANeRNCT04298736
Bariatric Surgery vs. Lifestyle Modification for NASH
A study testing Bariatric Surgery and Lifestyle modification in people with NASH - Nonalcoholic Steatohepatitis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Randomized Controlled Trial comparing the effects of Bariatric Surgery vs. Lifestyle modification on NASH resolution. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- Bariatric Surgery and Lifestyle modification
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Feb 2020to 20 Mar 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI between 30 and 45
- with biopsy-proven NASH
- with or without type 2 diabetes
- that fit for bariatric surgery.
Who cannot join
- borderline NASH ou cirrhosis;
- alcohol consumption (> 20 g/day for men and > 10 g/day for women, for the last 2 years);
- other hepatic diseases (such as viral hepatitis, autoimmune hepatitis, drug-induced hepatic disease, Wilson's disease, hemochromatosis);
- HIV infection;
- unable to provide informed consent;
- previous foregut or bariatric surgery;
- malignancy;
- patients that unfit for bariatric surgery.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Guilherme S Mazzini, MD, PhD, +55(51)981364873, guimazzini@gmail.com
About this study
Official title: Bariatric Surgery vs. Lifestyle Modification: Effects Against Nonalcoholic Steatohepatitis Randomized Trial
Randomized Controlled Trial comparing the effects of Bariatric Surgery vs. Lifestyle modification on NASH resolution.
Read the detailed description
Patients with biopsy-proven NASH will be randomized to either bariatric surgery or lifestyle interventions. After 1-year follow-up a liver biopsy will be done to evaluate NASH resolution
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- Bariatric Surgery, Lifestyle modification
- 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.
Bariatric SurgeryProcedure or surgery
laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy
Lifestyle modificationBehavioural
guided low-calorie diet and physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Experimental | Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to either laparoscopic Roux-en-Y Gastric Bypass or laparoscopic Sleeve Gastrectomy Receives: Procedure: Bariatric Surgery |
| Lifestyle Modification | Active comparator | Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to guided diet and physical activity. Receives: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
NASH resolution
NASH resolution evaluated by liver biopsy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start19 Feb 2020
- Primary completion20 Mar 2022 (estimated)
- Study completion20 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guilherme S Mazzini, MD, PhD, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298736
- Sponsor's protocol ID
- 2019-0780
- Acronym
- BeLEANeR
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery vs. Lifestyle Modification: Effects Against Nonalcoholic Steatohepatitis Randomized Trial
- ClinicalTrials.gov ID
- NCT04298736
- Acronym / sponsor ID
- BeLEANeR / 2019-0780
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 19 Feb 2020 (actual)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 20 Mar 2022 (estimated)
- First posted
- 6 Mar 2020 (actual)
- 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.
Randomized Controlled Trial comparing the effects of Bariatric Surgery vs. Lifestyle modification on NASH resolution.
Detailed description
Patients with biopsy-proven NASH will be randomized to either bariatric surgery or lifestyle interventions. After 1-year follow-up a liver biopsy will be done to evaluate NASH resolution
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | Experimental | Procedure: Bariatric SurgeryObese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to either laparoscopic Roux-en-Y Gastric Bypass or laparoscopic Sleeve Gastrectomy |
| Lifestyle Modification | Active comparator | Behavioral: Lifestyle modificationObese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to guided diet and physical activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- BMI between 30 and 45
- with biopsy-proven NASH
- with or without type 2 diabetes
- that fit for bariatric surgery.
Key exclusion criteria (8 listed)
- borderline NASH ou cirrhosis;
- alcohol consumption (> 20 g/day for men and > 10 g/day for women, for the last 2 years);
- other hepatic diseases (such as viral hepatitis, autoimmune hepatitis, drug-induced hepatic disease, Wilson's disease, hemochromatosis);
- HIV infection;
- unable to provide informed consent;
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 |
|---|---|---|
| Bariatric Surgerylaparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy | Procedure or surgery | Bariatric Surgery |
| Lifestyle modificationguided low-calorie diet and physical activity. | Behavioural | Lifestyle Modification |
Primary outcome
NASH resolution
Time frame: 12 months
NASH resolution evaluated by liver biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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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.
Guilherme S Mazzini, MD, PhD principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric Surgery and Lifestyle modification in people with NASH - Nonalcoholic Steatohepatitis, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 8 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. 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 Brazil. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guilherme S Mazzini, MD, PhD (+55(51)981364873, guimazzini@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NASH resolution (time frame: 12 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 6 Mar 2020.