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Identification of Protective and Worsening Steatohepatitis (NASH) Factors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2009 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00914446
First Posted: June 5, 2009
Last Update Posted: June 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Universitaire de Nice
  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: None (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 ]

Secondary Outcome Measures:
  • Seek protective and worsening factors by "microarray" [ Time Frame: one day ]
  • Quantitative analyses of genes of interest in the liver and and visceral adipose tissue [ Time Frame: one day ]
  • Immunohistochemical analyses [ Time Frame: one day ]
  • Biochemical analyses [ Time Frame: one day ]
  • Serum dosage of protein of interest [ Time Frame: one day ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 15, 2009
First Posted: June 5, 2009
Last Update Posted: June 5, 2009
Last Verified: June 2009

Keywords provided by Centre Hospitalier Universitaire de Nice:
Steatohepatitis

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