NCT03472157

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
26mo left

Started Jun 2018

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jun 2018Jun 2028

First Submitted

Initial submission to the registry

February 13, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2028

Last Updated

April 22, 2026

Status Verified

April 1, 2026

Enrollment Period

10 years

First QC Date

February 13, 2018

Last Update Submit

April 21, 2026

Conditions

SurgeryObesityNASH - Nonalcoholic SteatohepatitisCirrhosis

Keywords

Gastric bypassSleeve gastrectomyLifestyle therapyNASHAdvanced fibrosisCirrhosis

Outcome Measures

Primary Outcomes (1)

  • Rate of disappearance of NASH without worsening of fibrosis grade

    Diagnosis of NASH on the liver biopsy

    at 60 weeks after randomization

Secondary Outcomes (22)

  • Change in the NAS (Nafld Activity Score) score

    at 60 weeks after randomization

  • Percentage of patients achieving at least a 2 point improvement in the NAS (≥2 points) without worsening of fibrosis grade

    at 60 weeks after randomization

  • Change in the Brunt fibrosis score,

    at 60 weeks after randomization

  • Change in the Metavir score

    at 60 weeks after randomization

  • Change in the fibrosis area

    at 60 weeks after randomization

  • +17 more secondary outcomes

Study Arms (2)

Bariatric surgery

EXPERIMENTAL

Two different types of bariatric surgery can be proposed: laparoscopic Roux-en-Y Gastric Bypass or a Laparoscopic sleeve gastrectomy. Decision of the surgery type will be made according to surgical expertise, habits of investigation centers and the patient's desire. All patients receive nutritional support and therapeutic education adapted to recommendations bariatric surgery care.

Procedure: Bariatric surgery

Lifestyle therapy

ACTIVE COMPARATOR

The group will received the medical standard treatment defined as lifestyle therapy combining diet with increased physical activity (standard treatment, control) (figure 1, design of study).

Other: Lifestyle therapy

Interventions

Lifestyle therapyOTHER

Lifestyle habits (caloric intake and exercise) + pedometer

Lifestyle therapy
Bariatric surgeryPROCEDURE

Two different types of bariatric surgery can be proposed: laparoscopic Roux-en-Y Gastric Bypass or a Laparoscopic sleeve gastrectomy

Bariatric surgery

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provide written informed consent and agree to comply to the study protocol prior to enrolment.
  • BMI and Brunt Fibriosis score:
  • For hypertensive patients, hypertension must be controlled by stable dose of anti-hypertensive medication for at least 2 months prior to screening (and the stable dose can be maintained throughout the study).
  • Female participating in the study must be either of non-child bearing (surgically sterilized at 6 month prior to screening or postmenopausal) or using an efficient contraception: hormonal contraception (including patch, contraceptive ring etc) intra-uterine device or other mechanical contraception
  • Patient agrees to come to the study visits within the protocol-specified delay

You may not qualify if:

  • Previous history of bariatric surgery (except gastric ring removed for more than 3 years).
  • Decompensated cirrhosis (MELD\> 7 CPT score\> 5, previous history of decompensation (encephalopathy, ascites, jaundice, varicose vein rupture)
  • Hepatocellular carcinoma
  • Platelets \<125 000; TP \<80%; bilirubin \<20 mmol / l; albumin \<35 g / L.
  • Other liver disease: alcohol consumption exceeding 20 g / day for women and 30g / day in men, HBV, HCV, CBP, CSP, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin.
  • Being processed Cancer (chemotherapy, radiotherapy or hormone therapy)
  • HIV positive patients
  • Patients who had an acute cardiovascular episode, coronary Heart Disease (Angina pectoris, myocardial infarction, revascularization procedure), stroke or TIA (Transient Ischemic Attack) within the 6 months prior to screening Recent cardiovascular events (stroke, myocardial infarcts, etc…) in the past 6 months.
  • Severe chronic respiratory disease.
  • Severe chronic cardiac insufficiency (grade III and IV of NYHA classification).
  • Pregnant or breastfeeding women.
  • Simultaneous enrollment in another clinical trial.
  • Drug abuse within the past year.
  • Patient with contra-indication for bariatric surgery
  • Gastic Banding, Biliopancreatic diversion and all the new bariatric surgery techniques are forbidden because the study design allow only the laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric Bypaass.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Claude Huriez, CHRU

Lille, France

RECRUITING

MeSH Terms

Conditions

ObesityNon-alcoholic Fatty Liver DiseaseFibrosis

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Philippe Mathurin, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Mathurin, MD,PhD

CONTACT

3 20 44 53 21philippe.mathurin@chru-lille.fr

Guillaume Lassailly, MD

CONTACT

3 20 44 53 21guillaume.lassailly@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2018

First Posted

March 21, 2018

Study Start

June 20, 2018

Primary Completion (Estimated)

June 20, 2028

Study Completion (Estimated)

June 20, 2028

Last Updated

April 22, 2026

Record last verified: 2026-04

Locations

FR(1)