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

Primary Purpose

Obesity

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

biopsy of muscle, of liver, and of adipose tissue

clamp euglycemic - hyperglycemic

diet

biopsies for biological and genetic analyses

About this trial

This is an interventional diagnostic trial for Obesity focused on measuring bariatric surgery planned

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

CHU de Nantes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm Description

Non diabetic non dyslipidemic patient

Patient with metabolic syndrome

Patients with type II diabetes

Patient with a single lipidic anomaly

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00422006

First Posted

January 12, 2007

Last Updated

April 2, 2014

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00422006

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

bariatric surgery planned

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

111 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Non diabetic non dyslipidemic patient

Arm Title

Arm Type

Experimental

Arm Description

Patient with metabolic syndrome

Arm Title

Arm Type

Experimental

Arm Description

Patients with type II diabetes

Arm Title

Arm Type

Experimental

Arm Description

Patient with a single lipidic anomaly

Intervention Type

Procedure

Intervention Name(s)

biopsy of muscle, of liver, and of adipose tissue

Intervention Description

biopsy of muscle, of liver, and of adipose tissue

Intervention Type

Procedure

Intervention Name(s)

clamp euglycemic - hyperglycemic

Intervention Description

clamp euglycemic-hyperglycemic

Intervention Type

Behavioral

Intervention Name(s)

diet

Intervention Description

diet

Intervention Type

Other

Intervention Name(s)

biopsies for biological and genetic analyses

Intervention Description

biopsies for biological and genetic analyses

Primary Outcome Measure Information:

Title

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials: