Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05085769
Status:
COMPLETED
Last Update Posted:
2021-10-20
First Post:
2021-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery
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': 'D050110', 'term': 'Bariatric Surgery'}], 'ancestors': [{'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-19', 'studyFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2021-10-19', 'lastUpdatePostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in body weight', 'timeFrame': '6 months', 'description': 'Changes in body weight in kilograms'}, {'measure': 'Changes in body mass index', 'timeFrame': '6 months', 'description': 'Changes in body mass index in kg/m\\^2'}, {'measure': 'Changes in body fat and fat free mass', 'timeFrame': '6 months', 'description': 'Changes in fat mass and fat free mass in kilograms'}, {'measure': 'Changes in waist circumferences', 'timeFrame': '6 months', 'description': 'Changes in waist circumferences in centimeters'}, {'measure': 'Changes in serum glucose levels', 'timeFrame': '6 months', 'description': 'Changes in serum glucose in mg/dL'}, {'measure': 'Changes in lipid related biochemical parameters', 'timeFrame': '6 months', 'description': 'Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mg/dL'}, {'measure': 'Changes in liver function tests', 'timeFrame': '6 months', 'description': 'Changes in ALT and AST levels in U/L'}, {'measure': 'Changes in serum IL-6 and TNF-alpha levels', 'timeFrame': '6 months', 'description': 'Changes in serum IL-6 and TNF-alpha levels in ng/mL'}, {'measure': 'Changes in serum hs-CRP levels', 'timeFrame': '6 months', 'description': 'Changes in serum hs-CRP in mg/L'}], 'primaryOutcomes': [{'measure': 'Changes in gut microbial profiles of participants', 'timeFrame': '6 months', 'description': 'Changes in bacterial phyla and sub-phylum levels'}, {'measure': 'Changes in gut bacterial biodiversity of participants', 'timeFrame': '6 months', 'description': 'Changes in gut bacterial alpha and beta biodiversity of participants'}], 'secondaryOutcomes': [{'measure': 'Changes in dietary energy and nutrient intakes', 'timeFrame': '6 months', 'description': 'Changes in dietary energy in calories, macro-, micronutrient intakes in grams'}, {'measure': 'Changes in food intakes', 'timeFrame': '6 months', 'description': 'Changes in certain food groups in grams'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'bariatric surgery', 'gut microbiome', 'diet'], 'conditions': ['Obesity', 'Bariatric Surgery']}, 'referencesModule': {'references': [{'pmid': '39824262', 'type': 'DERIVED', 'citation': 'Ozdemir A, Sarzhanov F, Dogruman-Al F, Gundogdu A, Nalbantoglu U, Yozgat A, Yildiz BD, Buyuktuncer Z. Exploring the complex interplay of Blastocystis, morbid obesity, and bariatric surgery on gut microbial dynamics. Microb Pathog. 2025 Mar;200:107306. doi: 10.1016/j.micpath.2025.107306. Epub 2025 Jan 15.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to examine the effects of obesity and bariatric surgery on gut microbiota in a Turkish population, and to contribute to the literature by bringing multi-dimensional parameters including dietary intake, metabolic and inflammatory markers. This case-control study was conducted between June 2015 and August 2019. All participants were followed during the six-month period. Face-to-face interviews and physical examinations were held, and blood and fecal samples were collected at the baseline (M0) and at the end of 3 (M3) and 6 months (M6). Dietary intakes of subjects were assessed using 24-h dietary recall method in each interview and a detailed quantitative food frequency questionnaire that involved 85 food items. Subjects were recruited to the study as three groups: 15 patients who had bariatric surgery as study group, 8 morbidly obese participants who did not have bariatric surgery as control group-1 and 11 participants who were non-obese (lean (n=5) and pre-obese (n=6)) as control group-2. All subjects in the study group had sleeve gastrectomy. Subjects in control groups were selected as age and gender matched with the participants in the study group. Individuals were excluded if (a) they were under 19 or above 65 years old, (b) they had an acute or chronic inflammatory disease, (c) they were diagnosed with infectious diseases, cancer or alcohol addiction, (d) they used antibiotics in last 3 months before the screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '26 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects were recruited to the study as three groups: 15 patients who had bariatric surgery as study group, 8 morbidly obese participants who did not have bariatric surgery as control group-1 and 11 participants who were non-obese (lean (n=5) and pre-obese (n=6)) as control group-2.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* morbidly obese participants for study and control group-1\n* non-obese participants for control group-2\n\nExclusion Criteria:\n\n* they were under 19 or above 65 years old,\n* they had an acute or chronic inflammatory disease,\n* they were diagnosed with infectious diseases, cancer or alcohol addiction,\n* they used antibiotics in last 3 months before the screening.'}, 'identificationModule': {'nctId': 'NCT05085769', 'briefTitle': 'Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery', 'orgStudyIdInfo': {'id': 'GO14/533'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': '15 patients who had bariatric surgery', 'interventionNames': ['Procedure: Bariatric surgery']}, {'label': 'Control group-1', 'description': '8 morbidly obese participants who did not have bariatric surgery'}, {'label': 'Control group-2', 'description': '11 participants who were non-obese'}], 'interventions': [{'name': 'Bariatric surgery', 'type': 'PROCEDURE', 'description': 'A procedure for morbidly obese patients whose body mass index (BMI) is higher than 40 kg/m2 or 35 kg/m2 and having comorbidities of obesity.', 'armGroupLabels': ['Study group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant', 'investigatorFullName': 'Aslihan Ozdemir', 'investigatorAffiliation': 'Hacettepe University'}}}}