Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 11:30 AM
Study NCT ID:
NCT00422006
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2007-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008110', 'term': 'Liver Extracts'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D014020', 'term': 'Tissue Extracts'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2007-01-12', 'studyFirstSubmitQcDate': '2007-01-12', 'lastUpdatePostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bariatric surgery planned'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '32032671', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* corporal mass index \\> 40 kg/m² or \\> 35 kg/m² associated to a co-morbidity resistant to a diet\n* bariatric surgery planned\n* no lipid-lowering drugs during 4 weeks before surgery\n* no treatment by metformin during 4 weeks before surgery\n* no treatment by glitazones during 8 weeks before surgery\n* age of the patient between 18 and 65 years\n* consent form signed\n* patient with social insurance\n\nExclusion Criteria:\n\n* age inferior to 18 years\n* women pregnant\n* coagulation troubles\n* surgery contraindicated\n* Chronic hepatitis B or C active\n* VIH infected\n* other chronic hepatic disease\n* patient with dyslipidemia under lipid-lowering drugs in secondary prevention of a cardiovascular pathology\n* Type 2 diabetes under insulinosensitivator treatments'}, 'identificationModule': {'nctId': 'NCT00422006', 'briefTitle': 'Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Study of the Role of PCSK9 and FXR in the Physiopathology of the Joint Dyslipidemia Associated to the Human Immunoresistance', 'orgStudyIdInfo': {'id': 'BRD 06/8-I'}, 'secondaryIdInfos': [{'id': 'ID RCB 2006-A00196-45'}, {'id': 'DGS2006-0090'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Non diabetic non dyslipidemic patient', 'interventionNames': ['Procedure: biopsy of muscle, of liver, and of adipose tissue', 'Procedure: clamp euglycemic - hyperglycemic', 'Behavioral: diet', 'Other: biopsies for biological and genetic analyses']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Patient with metabolic syndrome', 'interventionNames': ['Procedure: biopsy of muscle, of liver, and of adipose tissue', 'Procedure: clamp euglycemic - hyperglycemic', 'Behavioral: diet', 'Other: biopsies for biological and genetic analyses']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Patients with type II diabetes', 'interventionNames': ['Procedure: biopsy of muscle, of liver, and of adipose tissue', 'Procedure: clamp euglycemic - hyperglycemic', 'Behavioral: diet', 'Other: biopsies for biological and genetic analyses']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Patient with a single lipidic anomaly', 'interventionNames': ['Procedure: biopsy of muscle, of liver, and of adipose tissue', 'Procedure: clamp euglycemic - hyperglycemic', 'Behavioral: diet', 'Other: biopsies for biological and genetic analyses']}], 'interventions': [{'name': 'biopsy of muscle, of liver, and of adipose tissue', 'type': 'PROCEDURE', 'description': 'biopsy of muscle, of liver, and of adipose tissue', 'armGroupLabels': ['1', '2', '3', '4']}, {'name': 'clamp euglycemic - hyperglycemic', 'type': 'PROCEDURE', 'description': 'clamp euglycemic-hyperglycemic', 'armGroupLabels': ['1', '2', '3', '4']}, {'name': 'diet', 'type': 'BEHAVIORAL', 'description': 'diet', 'armGroupLabels': ['1', '2', '3', '4']}, {'name': 'biopsies for biological and genetic analyses', 'type': 'OTHER', 'description': 'biopsies for biological and genetic analyses', 'armGroupLabels': ['1', '2', '3', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'overallOfficials': [{'name': 'Bertrand Cariou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Michel Krempf, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Yassine Zaïr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Eric Letessier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}, {'name': 'Charles Couet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Tours'}, {'name': 'Noël Huten, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Tours'}, {'name': 'Philippe Topart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Brest'}, {'name': 'David Lechaux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de St Brieuc'}, {'name': 'Jean-Pierre Faure, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Poitiers University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}