Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2025-12-29 @ 10:40 PM
Study NCT ID:
NCT01277068
Status:
COMPLETED
Last Update Posted:
2015-08-24
First Post:
2011-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2015-08-21', 'studyFirstSubmitDate': '2011-01-13', 'studyFirstSubmitQcDate': '2011-01-13', 'lastUpdatePostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL', 'timeFrame': '36 months', 'description': 'the 3 bariatric surgery procedures are: the adjustable gastric banding the sleeve gastrectomy the gastric bypass (associating a malabsorption).'}], 'secondaryOutcomes': [{'measure': 'to compare the production rates of these TRL before and after the bariatric surgery', 'timeFrame': '36 months', 'description': 'TRL particles is one of the characteristics, represents a major cardiovascular risk factor. The overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is a constituent recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obese patients', 'TRL', 'the bariatric surgery'], 'conditions': ['Obese Patients', 'Production Rates of These TRL Before and After the Bariatric Surgery', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '38491190', 'type': 'DERIVED', 'citation': 'Frances L, Croyal M, Ruidavets JB, Maraninchi M, Combes G, Raffin J, de Souto Barreto P, Ferrieres J, Blaak EE, Perret B, Moro C, Valero R, Martinez LO, Viguerie N. Identification of circulating apolipoprotein M as a new determinant of insulin sensitivity and relationship with adiponectin. Int J Obes (Lond). 2024 Jul;48(7):973-980. doi: 10.1038/s41366-024-01510-w. Epub 2024 Mar 15.'}, {'pmid': '25104797', 'type': 'DERIVED', 'citation': 'Padilla N, Maraninchi M, Beliard S, Berthet B, Nogueira JP, Wolff E, Nicolay A, Begu A, Dubois N, Grangeot R, Mattei C, Vialettes B, Xiao C, Lewis GF, Valero R. Effects of bariatric surgery on hepatic and intestinal lipoprotein particle metabolism in obese, nondiabetic humans. Arterioscler Thromb Vasc Biol. 2014 Oct;34(10):2330-7. doi: 10.1161/ATVBAHA.114.303849. Epub 2014 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'Morbidly obesity (body mass index 40 kg/m²), the most serious, is more and more frequent. Cardiovascular diseases are the first cause of morbidity and mortality. An excess of TRL particles is one of the characteristics, represents a major cardiovascular risk factor. The overproduction of the intestinal TRL (which apoprotein B48 is the specific tracer) is recently recognized of insulin-resistance and the atherogenous role of these intestinal TRL has been shown. In front of this important overmortality, the bariatric surgery quickly developed. Three main procedures are performed: 2 based exclusively on the gastric restriction (the adjustable gastric banding and the sleeve gastrectomy) and one associating a malabsorption (the gastric bypass).', 'detailedDescription': 'It is a monocentric, prospective, comparative study. After identification of the eligible subjects, the kinetics (production and clearance rates) of the intestinal TRL will be performed in the hospital, using a stable isotope method (5,5,5-D3-L-Leucine), in 3 groups of obese patients (12 patients per surgery procedure), before and 6 months after the surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women from 18 to 65 years old\n* Subject having a BMI included between 35 and 40 kg / m2 associated to at least a comorbidity susceptible to be improved after the surgery\n* Subject in failure of a medical treatment, led by an expert in nutrition, associating a dietary coverage and a physical activity adapted for at least 6 months\n* Subject without contraindication for 3 studied surgical techniques\n* Subject without cardiovascular events 6 months ago\n* subject is informed and is consented\n* Subject having a biologic balance dating less than 3 months\n\nExclusion Criteria:\n\n* subject with contraindication for 3 studied surgical techniques\n* women pregnant\n* subject did not consent and is not informed'}, 'identificationModule': {'nctId': 'NCT01277068', 'briefTitle': 'Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'Effects of Various Bariatric Surgical Procedures on Intestinal Triglyceride-rich-lipoprotein (TRL) Metabolism in Obese Patients', 'orgStudyIdInfo': {'id': '2010-A00844-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'the adjustable gastric banding', 'interventionNames': ['Procedure: Surgical and medical procedures']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the sleeve gastrectomy', 'interventionNames': ['Procedure: Surgical and medical procedures']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'the gastric bypass', 'interventionNames': ['Procedure: Surgical and medical procedures']}], 'interventions': [{'name': 'Surgical and medical procedures', 'type': 'PROCEDURE', 'description': 'this study want to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL: the adjustable gastric banding the sleeve gastrectomy the gastric bypass', 'armGroupLabels': ['the adjustable gastric banding', 'the gastric bypass', 'the sleeve gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique - Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'René Valero, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'APHM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}