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

NCT ID: NCT00422006

Last Updated: 2014-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2013-11-30

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Non diabetic non dyslipidemic patient

Group Type: EXPERIMENTAL

biopsy of muscle, of liver, and of adipose tissue

Intervention Type: PROCEDURE

biopsy of muscle, of liver, and of adipose tissue

clamp euglycemic - hyperglycemic

Intervention Type: PROCEDURE

clamp euglycemic-hyperglycemic

diet

Intervention Type: BEHAVIORAL

diet

biopsies for biological and genetic analyses

Intervention Type: OTHER

biopsies for biological and genetic analyses

2

Patient with metabolic syndrome

Group Type: EXPERIMENTAL

biopsy of muscle, of liver, and of adipose tissue

Intervention Type: PROCEDURE

biopsy of muscle, of liver, and of adipose tissue

clamp euglycemic - hyperglycemic

Intervention Type: PROCEDURE

clamp euglycemic-hyperglycemic

diet

Intervention Type: BEHAVIORAL

diet

biopsies for biological and genetic analyses

Intervention Type: OTHER

biopsies for biological and genetic analyses

3

Patients with type II diabetes

Group Type: EXPERIMENTAL

biopsy of muscle, of liver, and of adipose tissue

Intervention Type: PROCEDURE

biopsy of muscle, of liver, and of adipose tissue

clamp euglycemic - hyperglycemic

Intervention Type: PROCEDURE

clamp euglycemic-hyperglycemic

diet

Intervention Type: BEHAVIORAL

diet

biopsies for biological and genetic analyses

Intervention Type: OTHER

biopsies for biological and genetic analyses

4

Patient with a single lipidic anomaly

Group Type: EXPERIMENTAL

biopsy of muscle, of liver, and of adipose tissue

Intervention Type: PROCEDURE

biopsy of muscle, of liver, and of adipose tissue

clamp euglycemic - hyperglycemic

Intervention Type: PROCEDURE

clamp euglycemic-hyperglycemic

diet

Intervention Type: BEHAVIORAL

diet

biopsies for biological and genetic analyses

Intervention Type: OTHER

biopsies for biological and genetic analyses

Interventions

biopsy of muscle, of liver, and of adipose tissue

biopsy of muscle, of liver, and of adipose tissue

Intervention Type: PROCEDURE

clamp euglycemic - hyperglycemic

clamp euglycemic-hyperglycemic

Intervention Type: PROCEDURE

diet

diet

Intervention Type: BEHAVIORAL

biopsies for biological and genetic analyses

biopsies for biological and genetic analyses

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertrand Cariou, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Michel Krempf, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Yassine Zaïr, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Eric Letessier, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Charles Couet, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Tours

Noël Huten, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Tours

Philippe Topart, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Brest

David Lechaux, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de St Brieuc

Jean-Pierre Faure, MD

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

CHU de Nantes

Nantes, , France

Countries

France

References

Blanchard C, Ledoux S, Verhaegen A, Wargny M, Letessier E, Stepanian A, Huten N, Jacobi D, Krempf M, Le Bras M, Perrocheau Guillouche M, Arnaud L, Pichelin M, Van Gaal L, Cariou B, Le May C. Roux-en-Y gastric bypass, but not sleeve gastrectomy, decreases plasma PCSK9 levels in morbidly obese patients. Diabetes Metab. 2020 Nov;46(6):480-487. doi: 10.1016/j.diabet.2020.01.003. Epub 2020 Feb 4.

Reference Type: DERIVED

PMID: 32032671 (View on PubMed)

Other Identifiers

ID RCB 2006-A00196-45

Identifier Type: -

Identifier Source: secondary_id

DGS2006-0090

Identifier Type: -

Identifier Source: secondary_id

BRD 06/8-I

Identifier Type: -

Identifier Source: org_study_id