Fatty Liver and Ectopic Fat in Overweight and Obese Patients

• Sponsor: Centre Hospitalier Universitaire de Nice (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00886301
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 39
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Steatohepatitis	Procedure: liver biopsy	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Fatty Liver and Ectopic Fat in Overweight and Obese Patients
• Study Start Date: Mar 1, 2010
• Anticipated Primary Completion Date: Jun 1, 2013
• Anticipated Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 obese or overweight patients with fatty liver or ectopic fat	Procedure: liver biopsy; liver biopsy

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients. [at year 1]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hepatogastroenterology, Hôpital l'Archet, CHU de Nice	Nice		France	06000

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nice

Investigators

• Principal Investigator: Rodolphe ANTY, Dr, Hepatogastroentérology, CHU de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00886301
• Other Study ID Numbers: 08-PP-08
• First Posted: Apr 22, 2009
• Last Update Posted: Mar 30, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: overweight; obesity; steatohepatitis; ectopic fat
• Additional relevant MeSH terms: Fatty Liver; Cardiac Complexes, Premature; Overweight

Study Results

No Results Posted as of Mar 30, 2010