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
  Purpose

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.


Condition Intervention
Obesity
Procedure: biopsy of muscle, of liver, and of adipose tissue
Procedure: clamp euglycemic - hyperglycemic
Behavioral: diet
Other: biopsies for biological and genetic analyses

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 111
Study Start Date: February 2008
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Non diabetic non dyslipidemic patient
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: 2
Patient with metabolic syndrome
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: 3
Patients with type II diabetes
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: 4
Patient with a single lipidic anomaly
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00422006

Locations
France
CHU de Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00422006     History of Changes
Other Study ID Numbers: BRD 06/8-I, ID RCB 2006-A00196-45, DGS2006-0090
Study First Received: January 12, 2007
Last Updated: April 2, 2014
Health Authority: France: Direction Générale de la Santé

Keywords provided by Nantes University Hospital:
bariatric surgery planned

Additional relevant MeSH terms:
Obesity
Dyslipidemias
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014