Trials / Recruiting
RecruitingNCT03472157
A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients
Prospective Multicentric, Open Label, Randomized Clinical Trial of Superiority, With Two Arms, Comparing Bariatric Surgery to the Recommended Medical Treatment for NASH
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The aim of the study is to demonstrate the superiority of bariatric surgery on the disappearance of NASH without worsening of fibrosis in comparison to medical standard treatment in obese patients (35 kg/m² \> BMI ≥ 30 kg/m²) with NASH complicated of advanced fibrosis (F3 and F4 fibrosis grade according to Brunt score).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Lifestyle therapy | Lifestyle habits (caloric intake and exercise) + pedometer |
| PROCEDURE | Bariatric surgery | Two different types of bariatric surgery can be proposed: laparoscopic Roux-en-Y Gastric Bypass or a Laparoscopic sleeve gastrectomy |
Timeline
- Start date
- 2018-06-20
- Primary completion
- 2026-10-01
- Completion
- 2026-10-01
- First posted
- 2018-03-21
- Last updated
- 2026-04-07
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03472157. Inclusion in this directory is not an endorsement.