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Identification of Protective and Worsening Steatohepatitis (NASH) Factors

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.
 
ClinicalTrials.gov Identifier: NCT00914446
Recruitment Status : Unknown
Verified June 2009 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
First Posted : June 5, 2009
Last Update Posted : June 5, 2009
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice

Brief Summary:
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 or disease Intervention/treatment Phase
Morbid Obesity Steatohepatitis Steatosis Procedure: hepatic biopsies Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
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
Study Start Date : April 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
morbid obese subject Procedure: hepatic biopsies
hepatic biopsies

overweight and NASH subjects Procedure: hepatic biopsies
hepatic biopsies

control subjects Procedure: hepatic biopsies
hepatic biopsies




Primary Outcome Measures :
  1. Anatomopathologic study of the hepatic biopsies. [ Time Frame: one day ]

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


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

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

Locations
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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
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Principal Investigator: ALBERT TRAN, Ph D Centre Hospitalier Universitaire de Nice
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Responsible Party: Département de la Recherche Clinique - Mme MALERBA, Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT00914446    
Other Study ID Numbers: 07-APR-05
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: June 5, 2009
Last Verified: June 2009
Keywords provided by Centre Hospitalier Universitaire de Nice:
Steatohepatitis
Additional relevant MeSH terms:
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Fatty Liver
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Liver Diseases
Digestive System Diseases