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Completed

NCT Number: NCT00422006

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

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biopsy of muscle, of liver, and of adipose tissue

Procedure

biopsy of muscle, of liver, and of adipose tissue

clamp euglycemic - hyperglycemic

Procedure

clamp euglycemic-hyperglycemic

Diet

Behavioral

diet

biopsies for biological and genetic analyses

Other

biopsies for biological and genetic analyses

Primary outcomes

  1. 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

    Time frame: 2 years

Secondary outcomes

  1. 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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 15, 2007
Registry last updated
Apr 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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