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Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00422006
First received: January 12, 2007
Last updated: April 2, 2014
Last verified: April 2014

January 12, 2007
April 2, 2014
February 2008
November 2013   (final data collection date for primary outcome measure)
To evaluate the relationship between the expression levels of PCSK9 and FXR in the liver, adipose tissue and muscle and the different components of the insulin resistance syndrome obese patients submitted to bariatric surgery [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00422006 on ClinicalTrials.gov Archive Site
Relationship between the levels of hepatic expression of PCSK9 and FXR and the degree of NASH in these patients. - Search for mutations and polymorphisms in the gene PCSK9 and FXR and their promoter regions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance
Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance

Experimental results are strongly suggesting that PCSK9 and FXR could occur in the physiopathology of human joined dyslipidemia. But no data in the literature can validate the potential role of these two genes in the lipidic and glucidic metabolism control in physiopathological situations. This protocol is based on the hypothesis that the expression levels of PCSK 9 and FXR are modified for some patients suffering from insulin resistance and dyslipidemia.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Obesity
  • Procedure: biopsy of muscle, of liver, and of adipose tissue
    biopsy of muscle, of liver, and of adipose tissue
  • Procedure: clamp euglycemic - hyperglycemic
    clamp euglycemic-hyperglycemic
  • Behavioral: diet
    diet
  • Other: biopsies for biological and genetic analyses
    biopsies for biological and genetic analyses
  • Experimental: 1
    Non diabetic non dyslipidemic patient
    Interventions:
    • Procedure: biopsy of muscle, of liver, and of adipose tissue
    • Procedure: clamp euglycemic - hyperglycemic
    • Behavioral: diet
    • Other: biopsies for biological and genetic analyses
  • Experimental: 2
    Patient with metabolic syndrome
    Interventions:
    • Procedure: biopsy of muscle, of liver, and of adipose tissue
    • Procedure: clamp euglycemic - hyperglycemic
    • Behavioral: diet
    • Other: biopsies for biological and genetic analyses
  • Experimental: 3
    Patients with type II diabetes
    Interventions:
    • Procedure: biopsy of muscle, of liver, and of adipose tissue
    • Procedure: clamp euglycemic - hyperglycemic
    • Behavioral: diet
    • Other: biopsies for biological and genetic analyses
  • Experimental: 4
    Patient with a single lipidic anomaly
    Interventions:
    • Procedure: biopsy of muscle, of liver, and of adipose tissue
    • Procedure: clamp euglycemic - hyperglycemic
    • Behavioral: diet
    • Other: biopsies for biological and genetic analyses
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • corporal mass index > 40 kg/m² or > 35 kg/m² associated to a co-morbidity resistant to a diet
  • bariatric surgery planned
  • no lipid-lowering drugs during 4 weeks before surgery
  • no treatment by metformin during 4 weeks before surgery
  • no treatment by glitazones during 8 weeks before surgery
  • age of the patient between 18 and 65 years
  • consent form signed
  • patient with social insurance

Exclusion Criteria:

  • age inferior to 18 years
  • women pregnant
  • coagulation troubles
  • surgery contraindicated
  • Chronic hepatitis B or C active
  • VIH infected
  • other chronic hepatic disease
  • patient with dyslipidemia under lipid-lowering drugs in secondary prevention of a cardiovascular pathology
  • Type 2 diabetes under insulinosensitivator treatments
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00422006
BRD 06/8-I, ID RCB 2006-A00196-45, DGS2006-0090
Yes
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Bertrand Cariou, MD CHU de Nantes
Principal Investigator: Michel Krempf, MD CHU de Nantes
Principal Investigator: Yassine Zaïr, MD CHU de Nantes
Principal Investigator: Eric Letessier, MD CHU de Nantes
Principal Investigator: Charles Couet, MD CHU de Tours
Principal Investigator: Noël Huten, MD CHU de Tours
Principal Investigator: Philippe Topart, MD CHU de Brest
Principal Investigator: David Lechaux, MD CHU de St Brieuc
Principal Investigator: Jean-Pierre Faure, MD Poitiers University Hospital
Nantes University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP