ObesityNCT00422006
Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance
A study testing biopsy of muscle, of liver, and of adipose tissue, clamp euglycemic - hyperglycemic and diet in people with Obesity, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- biopsy of muscle, of liver, and of adipose tissue, clamp euglycemic - hyperglycemic and diet
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age inferior to 18 years
- women pregnant
- coagulation troubles
- surgery contraindicated
- Chronic hepatitis B or C active
- VIH infected
Show all 9Show fewer
- other chronic hepatic disease
- patient with dyslipidemia under lipid-lowering drugs in secondary prevention of a cardiovascular pathology
- Type 2 diabetes under insulinosensitivator treatments
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- biopsy of muscle, of liver, and of adipose tissue, clamp euglycemic - hyperglycemic, diet, biopsies for biological and genetic analyses
- Keywords
- bariatric surgery planned
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy of muscle, of liver, and of adipose tissueProcedure or surgery
biopsy of muscle, of liver, and of adipose tissue
clamp euglycemic - hyperglycemicProcedure or surgery
clamp euglycemic-hyperglycemic
dietBehavioural
diet
biopsies for biological and genetic analysesOther
biopsies for biological and genetic analyses
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Non diabetic non dyslipidemic patient Receives: Procedure: biopsy of muscle, of liver, and of adipose tissue; Procedure: clamp euglycemic - hyperglycemic; Behavioral: diet; Other: biopsies for biological and genetic analyses |
| 2 | Experimental | Patient with metabolic syndrome Receives: Procedure: biopsy of muscle, of liver, and of adipose tissue; Procedure: clamp euglycemic - hyperglycemic; Behavioral: diet; Other: biopsies for biological and genetic analyses |
| 3 | Experimental | Patients with type II diabetes Receives: Procedure: biopsy of muscle, of liver, and of adipose tissue; Procedure: clamp euglycemic - hyperglycemic; Behavioral: diet; Other: biopsies for biological and genetic analyses |
| 4 | Experimental | Patient with a single lipidic anomaly Receives: Procedure: biopsy of muscle, of liver, and of adipose tissue; Procedure: clamp euglycemic - hyperglycemic; Behavioral: diet; Other: biopsies for biological and genetic analyses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2007 (estimated)
- Study startFeb 2008
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bertrand Cariou, MD, Principal investigator, Nantes University HospitalMichel Krempf, MD, Principal investigator, Nantes University HospitalYassine Zaïr, MD, Principal investigator, Nantes University HospitalEric Letessier, MD, Principal investigator, Nantes University HospitalCharles Couet, MD, Principal investigator, CHU de ToursNoël Huten, MD, Principal investigator, CHU de ToursPhilippe Topart, MD, Principal investigator, CHU de BrestDavid Lechaux, MD, Principal investigator, CHU de St Brieuc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422006
- Sponsor's protocol ID
- BRD/06/08-I
- Other IDs
- ID RCB 2006-A00196-45, DGS2006-0090
- Status last verified
- Apr 2014
- First submitted
- 12 Jan 2007
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pihan-Le Bars F, Bonnet F, Loreal O, Le Loupp AG, Ropert M, Letessier E, Prieur X, Bach K, Deugnier Y, Fromenty B, Cariou B. Indicators of iron status are correlated with adiponectin expression in adipose tissue of patients with morbid obesity. Diabetes Metab. 2016 Apr;42(2):105-11. doi: 10.1016/j.diabet.2015.10.007. Epub 2015 Dec 8.
PubMed 26677772Blanchard 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.
PubMed 32032671
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance
- ClinicalTrials.gov ID
- NCT00422006
- Acronym / sponsor ID
- BRD/06/08-I
- Conditions
- Obesity
- Keywords
- bariatric surgery planned
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: biopsy of muscle, of liver, and of adipose tissue, Procedure: clamp euglycemic - hyperglycemic, Behavioral: diet, Other: biopsies for biological and genetic analysesNon diabetic non dyslipidemic patient |
| 2 | Experimental | Procedure: biopsy of muscle, of liver, and of adipose tissue, Procedure: clamp euglycemic - hyperglycemic, Behavioral: diet, Other: biopsies for biological and genetic analysesPatient with metabolic syndrome |
| 3 | Experimental | Procedure: biopsy of muscle, of liver, and of adipose tissue, Procedure: clamp euglycemic - hyperglycemic, Behavioral: diet, Other: biopsies for biological and genetic analysesPatients with type II diabetes |
| 4 | Experimental | Procedure: biopsy of muscle, of liver, and of adipose tissue, Procedure: clamp euglycemic - hyperglycemic, Behavioral: diet, Other: biopsies for biological and genetic analysesPatient with a single lipidic anomaly |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- age inferior to 18 years
- women pregnant
- coagulation troubles
- surgery contraindicated
- Chronic hepatitis B or C active
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy of muscle, of liver, and of adipose tissuebiopsy of muscle, of liver, and of adipose tissue | Procedure or surgery | 1, 2, 3, 4 |
| clamp euglycemic - hyperglycemicclamp euglycemic-hyperglycemic | Procedure or surgery | 1, 2, 3, 4 |
| dietdiet | Behavioural | 1, 2, 3, 4 |
| biopsies for biological and genetic analysesbiopsies for biological and genetic analyses | Other | 1, 2, 3, 4 |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 26677772Pihan-Le Bars F, Bonnet F, Loreal O, Le Loupp AG, Ropert M, Letessier E, Prieur X, Bach K, Deugnier Y, Fromenty B, Cariou B. Indicators of iron status are correlated with adiponectin expression in adipose tissue of patients with morbid obesity. Diabetes Metab. 2016 Apr;42(2):105-11. doi: 10.1016/j.diabet.2015.10.007. Epub 2015 Dec 8.
- Derived from this study: PubMed 32032671Blanchard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertrand Cariou, MD principal investigator
Nantes University Hospital
Michel Krempf, MD principal investigator
Nantes University Hospital
Yassine Zaïr, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biopsy of muscle, of liver, and of adipose tissue, clamp euglycemic - hyperglycemic and diet in people with Obesity, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00422006, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.