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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422006
• Other study ID #: BRD 06/8-I
• Secondary ID: ID RCB 2006-A001
• Status: Completed
• Phase: N/A
• First received: January 12, 2007
• Last updated: April 2, 2014
• Start date: February 2008
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dyslipidemias
• Obesity

Intervention

Procedure:
• biopsy of muscle, of liver, and of adipose tissue
biopsy of muscle, of liver, and of adipose tissue
• clamp euglycemic - hyperglycemic
clamp euglycemic-hyperglycemic

Behavioral:
• diet
diet

Other:
• biopsies for biological and genetic analyses
biopsies for biological and genetic analyses

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No