Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance
Not Applicable
Completed
- Conditions
- Obesity
- Interventions
- Procedure: biopsy of muscle, of liver, and of adipose tissueProcedure: clamp euglycemic - hyperglycemicBehavioral: dietOther: biopsies for biological and genetic analyses
- Registration Number
- NCT00422006
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 111
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 biopsy of muscle, of liver, and of adipose tissue Non diabetic non dyslipidemic patient 1 clamp euglycemic - hyperglycemic Non diabetic non dyslipidemic patient 1 diet Non diabetic non dyslipidemic patient 1 biopsies for biological and genetic analyses Non diabetic non dyslipidemic patient 2 biopsy of muscle, of liver, and of adipose tissue Patient with metabolic syndrome 2 clamp euglycemic - hyperglycemic Patient with metabolic syndrome 2 diet Patient with metabolic syndrome 2 biopsies for biological and genetic analyses Patient with metabolic syndrome 3 biopsy of muscle, of liver, and of adipose tissue Patients with type II diabetes 3 clamp euglycemic - hyperglycemic Patients with type II diabetes 3 diet Patients with type II diabetes 3 biopsies for biological and genetic analyses Patients with type II diabetes 4 biopsy of muscle, of liver, and of adipose tissue Patient with a single lipidic anomaly 4 clamp euglycemic - hyperglycemic Patient with a single lipidic anomaly 4 diet Patient with a single lipidic anomaly 4 biopsies for biological and genetic analyses Patient with a single lipidic anomaly
- Primary Outcome Measures
Name Time Method 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 2 years
- Secondary Outcome Measures
Name Time Method 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 2 years
Trial Locations
- Locations (1)
CHU de Nantes
🇫🇷Nantes, France