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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00422006
Enrollment
111
Registered
2007-01-15
Start date
2008-02-01
Completion date
2013-11-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

bariatric surgery planned

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.

Interventions

PROCEDUREbiopsy of muscle, of liver, and of adipose tissue

biopsy of muscle, of liver, and of adipose tissue

PROCEDUREclamp euglycemic - hyperglycemic

clamp euglycemic-hyperglycemic

BEHAVIORALdiet

diet

OTHERbiopsies for biological and genetic analyses

biopsies for biological and genetic analyses

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 surgery2 years

Secondary

MeasureTime frame
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 regions2 years

Countries

France

Contacts

PRINCIPAL_INVESTIGATORBertrand Cariou, MD

Nantes University Hospital

PRINCIPAL_INVESTIGATORMichel Krempf, MD

Nantes University Hospital

PRINCIPAL_INVESTIGATORYassine Zaïr, MD

Nantes University Hospital

PRINCIPAL_INVESTIGATOREric Letessier, MD

Nantes University Hospital

PRINCIPAL_INVESTIGATORCharles Couet, MD

CHU de Tours

PRINCIPAL_INVESTIGATORNoël Huten, MD

CHU de Tours

PRINCIPAL_INVESTIGATORPhilippe Topart, MD

CHU de Brest

PRINCIPAL_INVESTIGATORDavid Lechaux, MD

CHU de St Brieuc

PRINCIPAL_INVESTIGATORJean-Pierre Faure, MD

Poitiers University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026