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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00422006

ID RCB 2006-A00196-45

BRD 06/8-I

DGS2006-0090

Details and patient eligibility

About

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.

Enrollment: 111 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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111 participants in 4 patient groups

1

Experimental group

Description:

Non diabetic non dyslipidemic patient

Treatment:

Other: biopsies for biological and genetic analyses

Behavioral: diet

Procedure: clamp euglycemic - hyperglycemic

Procedure: biopsy of muscle, of liver, and of adipose tissue

2

Experimental group

Description:

Patient with metabolic syndrome

Treatment:

Other: biopsies for biological and genetic analyses

Behavioral: diet

Procedure: clamp euglycemic - hyperglycemic

Procedure: biopsy of muscle, of liver, and of adipose tissue

3

Experimental group

Description:

Patients with type II diabetes

Treatment:

Other: biopsies for biological and genetic analyses

Behavioral: diet

Procedure: clamp euglycemic - hyperglycemic

Procedure: biopsy of muscle, of liver, and of adipose tissue

4

Experimental group

Description:

Patient with a single lipidic anomaly

Treatment:

Other: biopsies for biological and genetic analyses

Behavioral: diet

Procedure: clamp euglycemic - hyperglycemic

Procedure: biopsy of muscle, of liver, and of adipose tissue