NCT00886301

Brief Summary

The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2014

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

4.6 years

First QC Date

April 20, 2009

Last Update Submit

November 9, 2023

Conditions

Steatohepatitis

Keywords

overweightobesitysteatohepatitisectopic fat

Outcome Measures

Primary Outcomes (1)

  • Liver status will be will be determined by liver biopsy, non invasive liver assessment. Biological and medical imaging parameters will be use to characterize our patients.

    at inclusion and at year 1

Secondary Outcomes (1)

  • Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients.

    at year 1

Study Arms (1)

1

OTHER

obese or overweight patients with fatty liver or ectopic fat

Procedure: liver biopsy

Interventions

liver biopsyPROCEDURE

liver biopsy

1

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 25 and 40
  • ALAT level superior to normal level even after 3 months of diet
  • alcohol consumption \< 20 g/j for women and \< 30 g/j for men

You may not qualify if:

  • HIV, hepatitis B virus, hepatitis C virus positive
  • known hemochromatosis
  • glycemia \> 1.26 g/L or under anti-diabetic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hepatogastroenterology, Hôpital l'Archet, CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Fatty LiverOverweightObesity

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rodolphe ANTY, Dr

    Hepatogastroentérology, CHU de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

March 1, 2010

Primary Completion

October 2, 2014

Study Completion

October 2, 2014

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

FR(1)