Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-01 @ 7:14 AM
Study NCT ID:
NCT01454232
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2011-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adaptation of Human Gut Microbiota to Energetic Restriction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2011-10-07', 'studyFirstSubmitQcDate': '2011-10-14', 'lastUpdatePostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analyse changes early, medium and long term changes in gut microbiota composition in a kinetic manner', 'timeFrame': 'at 1, 3 and 12 months after surgery'}, {'measure': 'Compare gut microbiota kinetic changes in obese to gut microbiota healthy volunteers', 'timeFrame': 'at 1, 3 and 12 months after surgery in the obese group and compare it to baseline in lean subjects'}], 'secondaryOutcomes': [{'measure': 'Establish early, medium and long term changes in insulin sensitivity and GLP1 secretion profile after oral glucose load and look for potential associations between these changes and gut microbiota composition', 'timeFrame': '1, 3 and 12 months after surgery'}, {'measure': 'Establish early, medium and long term changes in systemic and adipose tissue inflammation and look for potential associations between gut microbiota composition and inflammation modification', 'timeFrame': '1, 3 and 12 months after surgery'}, {'measure': 'Establish early, medium and long term changes in body composition and look for potential associations between these changes and gut microbiota modifications', 'timeFrame': '1, 3 and 12 months after surgery'}, {'measure': 'Establish early, medium and long term changes in nutritional blood sample concentrations and look for a potential association between gut microbiota modifications.', 'timeFrame': '1, 3, 12 months after surgery'}, {'measure': 'Establish early, medium and long term improvement in obesity related disease (reducing the number of treatments and the need for PPC use) and look for potential association with gut microbiota modification', 'timeFrame': '1, 3 and 12 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Obesity', 'adipose tissue inflammation', 'Low grade systemic inflammation', 'gut microbiota', 'Bariatric surgery'], 'conditions': ['Obesity', 'Metabolic Diseases', 'Nutrition Disorders', 'Body Weight']}, 'referencesModule': {'references': [{'pmid': '37302712', 'type': 'DERIVED', 'citation': 'Torres L, Camila Goncalves Miranda M, Dantas Martins V, Caixeta F, de Almeida Oliveira M, Martins Trindade L, Carvalho de Assis H, Nascimento V, Pinheiro Rosa N, Gomes E, Oliveira Almeida S, Marquet F, Genser L, Marcelin G, Clement K, Russo M, Maria Caetano Faria A, Uceli Maioli T. Obesity-induced hyperglycemia impairs oral tolerance induction and aggravates food allergy. Mucosal Immunol. 2023 Aug;16(4):513-526. doi: 10.1016/j.mucimm.2023.05.008. Epub 2023 Jun 10.'}, {'pmid': '29899081', 'type': 'DERIVED', 'citation': 'Aron-Wisnewsky J, Prifti E, Belda E, Ichou F, Kayser BD, Dao MC, Verger EO, Hedjazi L, Bouillot JL, Chevallier JM, Pons N, Le Chatelier E, Levenez F, Ehrlich SD, Dore J, Zucker JD, Clement K. Major microbiota dysbiosis in severe obesity: fate after bariatric surgery. Gut. 2019 Jan;68(1):70-82. doi: 10.1136/gutjnl-2018-316103. Epub 2018 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'Gut microbiota ecology is altered in obesity and could link obesity and its complications. Bariatric surgery enables a major and sustained weight loss therefore improving obesity related disease.\n\nthe investigators primary aim is to evaluate gut microbiota adaptation to weight loss and the specific role of energetic restriction. Furthermore we aim to compare gut flora of obese patients post bariatric surgery to that of lean healthy volunteers.\n\nThus, the investigators plan to compare gut microbiota from 140 obese individuals before and after either restrictive (gastric banding) procedures or gastric bypass procedures to that of 40 lean healthy volunteers at baseline.', 'detailedDescription': 'The prevalence of obesity is rising to an epidemic level. Yet medical and pharmacological treatments have proven their limits. Dietetic modifications contribute to adipose tissue alterations and cross talk dysfunction with other tissues linked to weight maintenance. In a previous study in a model of abrupt weight loss 6 months after Roux-en-Y Bypass, the investigators observed a rapid adaptation of the dominant gut microbiota. Conversely some species were directly linked to the improvement of low grade inflammation independently of calory intake.\n\nTherefore the investigators hypothesized that gut microbiota in obese patients could link food consumption with obesity alterations such as metabolic impairments, energetic storage dysfunction and increased systemic and adipose tissue inflammation.\n\nThe investigators want to address the specific role of energetic restriction in gut microbiota modification after weight loss.\n\nTo answer that question the investigators will evaluate gut microbiota composition before and during the first year after either gastric banding or gastric bypass surgery. they also aim to evaluate whether gut flora post surgery evolves toward that of lean healthy subjects Our study has several objectives. The investigators also aim to assess whether gut microbiota modification is associated with systemic and tissue inflammation reduction and metabolic improvement during the follow up.\n\nThis project is based on a clinical protocol performed in massively obese subjects (BMI\\>40 kg/m²). The investigators plan to recruit 70 obese patients addressed for gastric banding and 70 candidates for gastric bypass. Clinical phenotype, biochemical analysis, body composition, systemic and adipose tissue inflammation, endotoxemia and gut microbiota will be assessed at baseline and 1, 3 and 12 months after surgery. Specific food consumption will be recorded at every time point. A group of 40 lean healthy volunteers will undergo the same phenotyping.\n\nAssociations between all these clinical and biological parameters will be assessed at the different point of the follow up.\n\nMore generally, this project might lead us to elucidate a new function of gut microbiota and eventually consider novels anti obesity therapeutic strategies'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Obese group\n\nInclusion criteria :\n\n* Obesity with BMI\\> 40 kg/m² or obesity with BMI between 35 and 40 kg/M² with comorbidities (OSA, type 2 diabetes, hypertension etc…)\n* Age: 18-65\n* women\n* weight stable for three months preceding surgery\n\nExclusion criteria :\n\n* Inflammatory disease\n* Pregnancy\n* Lactose intolerance\n* Antibiotherapy in the three months preceding surgery\n* cancer\n* Drugs (AINS)\n\nHealthy group\n\nInclusion criteria :\n\n* 19\\<BMI\\<25kg/m²\n* Age: 18-65\n* women\n* non diabetic\n\nExclusion criteria :\n\n* Inflammatory disease\n* Pregnancy\n* Antibiotherapy in the two months preceding the visit\n* pregnancy\n* Drugs (AINS) in the 48h preceding the visit'}, 'identificationModule': {'nctId': 'NCT01454232', 'acronym': 'microbaria', 'briefTitle': 'Adaptation of Human Gut Microbiota to Energetic Restriction', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Modification of Human Gut Microbiota in Massive Obesity After Bariatric Surgery: the Role of Energetic Restriction', 'orgStudyIdInfo': {'id': 'P100111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'gastric surgery', 'description': 'obese patients addressed for gastric surgery', 'interventionNames': ['Other: stools sampling', 'Other: adipose tissue biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lean healthy subjects evaluated once', 'description': 'lean healthy subjects evaluated once', 'interventionNames': ['Other: stools sampling', 'Other: adipose tissue biopsy']}], 'interventions': [{'name': 'stools sampling', 'type': 'OTHER', 'description': 'stools sampling at baseline, 1, 3 and 12 months', 'armGroupLabels': ['gastric surgery', 'lean healthy subjects evaluated once']}, {'name': 'adipose tissue biopsy', 'type': 'OTHER', 'description': 'surgical adipose tissue biopsy during surgery, 1, 3 and 12 months', 'armGroupLabels': ['gastric surgery', 'lean healthy subjects evaluated once']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Pitié Salpêtrière Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Karine Clement, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}