Trials Sponsors Conditions Drugs Pricing

Conditions

NASH - Nonalcoholic Steatohepatitis Obesity

Keywords

NAFLNASH screeningmetabolic syndromeDiagnostic Biomarkernon-invasive biomarker

Outcome Measures

Primary Outcomes (1)

The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)-NASH score
The variables constituting the calculation algorithm are : clinical data (age, gender, BMI, diabetes status), biological data (AST, ALT, GCT, fasting glucose, HbA1c, triglyceride,...) and genetic polymorphism
Baseline

Secondary Outcomes (2)

The Area under receiver operating characteristic (ROC) curve (AUC) of the LLIFT (Lille LIver Fat Test)- steatosis score
Baseline
Assessment of the correlation between the LLIFT score and the NAS score
Baseline

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Patients are followed in the cardiology, endocrinology, hepatology, hepatologic surgery and bariatric surgery units of the CHU de Lille and regional centers and presente type 2 diabetes or blood pressure hypertension associated with increased hepatic enzyme. Patients will be referred to the hepatology units and included in the study

You may qualify if:

Patients with 1 at least of the following metabolic criteria :

Sponsors & Collaborators

RHU PreciNASH Task 1.4
Type not reportedcollaborator
Région Nord-Pas de Calais, France
Othercollaborator
University Hospital, Lille

Study Sites (7)

Chu Amiens Picardie

Amiens, France

CH ARRAS

Arras, France

CH de Douai

Douai, France

CH LENS

Lens, France

Hop Claude Huriez Chu Lille

Lille, 59037, France

GHIRCL saint Philibert

Lomme, France

Ch Valenciennes

Valenciennes, France

MeSH Terms

Conditions

ObesityNon-alcoholic Fatty Liver DiseaseMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System DiseasesInsulin ResistanceHyperinsulinism

Study Officials

Guillaume Lassailly, MD
University Hospital, Lille
PRINCIPAL INVESTIGATOR

Enrollment

158 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 6, 2020

First Posted

November 5, 2020

Study Start

February 16, 2021

Actual (reported)

Diagnostic Accuracy of the "LLIFT", a Novel Non-invasive Biomarker for the Diagnosis of Non Alcoholic Fatty Liver (NAFL) and SteatoHepatitis (NASH) in a Population With High Risk of Metabolic Syndrome"

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations