Fatty Liver and Ectopic Fat in Overweight and Obese Patients | NCT00886301

Studies
Fatty Liver and Ectopic Fat in Overweight and Obese Patients

NCT00886301

Sponsor

Centre Hospitalier Universitaire de Nice

Status

Completed

Last Update Posted

Nov 13, 2023Actual

Enrollment

56Actual

Phase

Not Applicable

Conditions

Steatohepatitis

Interventions

liver biopsy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010Actual

Primary Completion Date

Oct 2, 2014Actual

Completion Date

Oct 2, 2014Actual

First Submitted Date

Apr 20, 2009

First Submission Date that Met QC Criteria

Apr 21, 2009

First Posted Date

Apr 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 9, 2023

Last Update Posted Date

Nov 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Non invasive assessment of liver fibrosis and liver inflammation and steatosis is clinically relevant in patients exposed to non alcoholic fatty liver diseases.

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.

Fatty liver and ectopic fat accumulation will be particularly assessed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	obese or overweight patients with fatty liver or ectopic fat	Procedure: liver biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liver biopsy	Procedure	liver biopsy	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients.		at year 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rodolphe ANTY, Dr	Hepatogastroentérology, CHU de Nice	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hepatogastroenterology, Hôpital l'Archet, CHU de Nice		Nice		06000	France

Condition Browse Module

MeSH Terms

ID	Term
D005234	Fatty Liver
D050177	Overweight
D009765	Obesity

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided