Identification of Protective and Worsening Steatohepatitis (NASH) Factors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00914446
First received: April 15, 2009
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

The main aim of this work will be to identify a profile of gene expression by microarray in the liver which might allow to differentiate obese subjects having a normal liver from those with steatohepatitis or steatosis.


Condition Intervention
Morbid Obesity
Steatohepatitis
Steatosis
Procedure: hepatic biopsies

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Identification of Protective and Worsening Steatohepatitis (NASH) Factors by Microarray in Morbid Obesity Patients

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Anatomopathologic study of the hepatic biopsies. [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Seek protective and worsening factors by "microarray" [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Quantitative analyses of genes of interest in the liver and and visceral adipose tissue [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Immunohistochemical analyses [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Biochemical analyses [ Time Frame: one day ] [ Designated as safety issue: No ]
  • Serum dosage of protein of interest [ Time Frame: one day ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2008
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
morbid obese subject Procedure: hepatic biopsies
hepatic biopsies
overweight and NASH subjects Procedure: hepatic biopsies
hepatic biopsies
control subjects Procedure: hepatic biopsies
hepatic biopsies

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for morbid obese subjects without diabetes:

  • 18-60 years old, male or female
  • Body mass index > 40 kg/m2
  • Obesity surgery required
  • Alcohol consumption < 20g per day
  • Affiliation to national French health insurance
  • Consent agreement

Exclusion criteria:

  • Hepatitis B, C, HIV
  • Pregnant or breast-feeding woman.
  • Inability to sign informed consent
  • Patient with regulatory authority patient gold private freedom
  • Hémochromatosis
  • Toxic Hepatitis
  • Alpha-1-anti-trypsin Deficiency
  • Wilson disease
  • Auto-immune hepatitis
  • Drug Hepatitis
  • Orlistat

Inclusion criteria for controls subjects:

  • Subjects of the 2 sexes of 18-60 years old
  • Patients with normal body mass index between 20-25 kg/m2
  • Patients profiting from hepatectomy for benign tumors like adenoma or bulky tumor hepatic biliary cyst or from a repair of the abdominal wall
  • Subjects affiliated to a mode of social security
  • Patient having signed the enlightened consent
  • The private subjects from freedom and the major subjects under supervision will be excluded

Inclusion criteria for overweight and NASH subjects:

  • Subjects of the 2 sexes of 18-60 years old
  • Patients with body mass index > 25 kg/m2
  • Alcohol Consumption < 20 g/j
  • Patient having a NASH in the hepatic biopsy
  • Subjects affiliated to a mode of social security
  • Patient having signed the enlightened consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914446

Contacts
Contact: ALBERT TRAN, Ph D +33 4 92 03 59 43 tran.a@chu-nice.fr

Locations
France
CHU de Nice Hôpital de l'Archet Recruiting
Nice, France, 06003
Contact: ALBERT TRAN, Ph D    + 33 4 92 03 59 43    tran.a@chu-nice.fr   
Principal Investigator: ALBERT TRAN, Ph D         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: ALBERT TRAN, Ph D CHU de Nice
  More Information

No publications provided

Responsible Party: Département de la Recherche Clinique - Mme MALERBA, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00914446     History of Changes
Other Study ID Numbers: 07-APR-05
Study First Received: April 15, 2009
Last Updated: June 4, 2009
Health Authority: France: French Data Protection Authority
France: Institutional Ethical Committee
France: Direction Générale de la Santé

Keywords provided by Centre Hospitalier Universitaire de Nice:
Steatohepatitis

Additional relevant MeSH terms:
Fatty Liver
Obesity
Obesity, Morbid
Body Weight
Digestive System Diseases
Liver Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014