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

N/ACompletedNCT00422006

Nantes University Hospital111 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

111

Conditions

Obesity

Interventions

biopsy of muscle, of liver, and of adipose tissuePROCEDURE

biopsy of muscle, of liver, and of adipose tissue

clamp euglycemic - hyperglycemicPROCEDURE

clamp euglycemic-hyperglycemic

dietBEHAVIORAL

diet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Nantes

Nantes, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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