Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-01-07 @ 12:46 AM
Study NCT ID:
NCT03296605
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-23
First Post:
2017-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Obesity and 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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, Adipose tissue, Liver tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-19', 'studyFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2017-09-25', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunity cells', 'timeFrame': 'up to 5 years', 'description': 'Ratio of immunity cells in circulating and adipose or liver tissue'}], 'secondaryOutcomes': [{'measure': 'Body weight and height', 'timeFrame': 'up to 5 years', 'description': 'Body weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Insulin', 'timeFrame': 'up to 5 years', 'description': 'Insulin (mIU/L) concentartions in serum and adipose tissue'}, {'measure': 'Cytokine', 'timeFrame': 'up to 5 years', 'description': 'Cytokines concentrations in circulating and adipose or liver tissue'}, {'measure': 'Cognitive Assessment (MMSE)', 'timeFrame': 'up to five years', 'description': 'Mini-Mental State Examination (MMSE) scores from 0-30, and the test means better cognition with a higher score.'}, {'measure': 'Cognitive Assessment (MoCA)', 'timeFrame': 'up to 5 years', 'description': 'The Montreal Cognitive Assessment (MoCA) scores from 0-30, and the test means better cognition with a higher score.'}, {'measure': 'Cognitive Assessment (RBANS)', 'timeFrame': 'up to 5 years', 'description': 'The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) scores from 0-800, and the test means better cognition with a higher score.'}, {'measure': 'Cognitive Assessment (processing speed)', 'timeFrame': 'up to 5 years', 'description': 'The Trial Making Test (TMT) provides a measure of processing speed, which consists of part A and part B (TMT-A and TMT-B). The time limits for performing the TMT-A and TMT-B are 180 and 300 seconds, respectively. Processing speed is estimated by the sum of the consuming time to complete TMT-A and TMT-B such that less time indicate faster processing speed.'}, {'measure': 'Cognitive Assessment (executive function)', 'timeFrame': 'up to 5 years', 'description': 'The Victoria Stroop Color-Word Test is a well-known measure of executive functioning. There are three indices including Stroop-dot, Stroop-word and Stroop-color word in the test. The color task consists of colored dots; the word task comprises ordinary words that are unrelated to the meaning of color; the color-word task consists of words written in color that indicate the meaning of the color, but the color of these words differs from the meaning of the word itself. The participants were asked to quickly read the color of the dots or Chinese words on the cards. The sum of consuming time taken to read the three cards is used as an index of executive function performance. Less time indicates better executive function.'}, {'measure': 'brain structure and activation in fMRI', 'timeFrame': 'up to 5 years', 'description': 'All patients underwent odor-induced task fMRI on a 3.0T MR scanner'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '36738300', 'type': 'DERIVED', 'citation': 'Tang W, Ge K, Shen L, Wang H, Feng W, Sun X, Chu X, Zhu D, Yin H, Bi Y. Th1 bias of liver mucosal-associated invariant T cells promotes hepatic gluconeogenesis in type 2 diabetes mellitus. Diabetes Metab Res Rev. 2023 May;39(4):e3620. doi: 10.1002/dmrr.3620. Epub 2023 Feb 17.'}, {'pmid': '33943025', 'type': 'DERIVED', 'citation': 'Liu F, He J, Liu B, Zhang P, Wang H, Sun X, Chu X, Guan W, Feng W, Bi Y, Zhu D. Association of Omental Adipocyte Hypertrophy and Fibrosis with Human Obesity and Type 2 Diabetes. Obesity (Silver Spring). 2021 Jun;29(6):976-984. doi: 10.1002/oby.23155. Epub 2021 May 4.'}, {'pmid': '30285651', 'type': 'DERIVED', 'citation': 'Yuan X, Chen J, Cheng Q, Zhao Y, Zhang P, Shao X, Bi Y, Shi X, Ding Y, Sun X, Xue B. Hepatic expression of Yin Yang 1 (YY1) is associated with the non-alcoholic fatty liver disease (NAFLD) progression in patients undergoing bariatric surgery. BMC Gastroenterol. 2018 Oct 3;18(1):147. doi: 10.1186/s12876-018-0871-2.'}, {'pmid': '29452209', 'type': 'DERIVED', 'citation': 'Zhang P, Ge Z, Wang H, Feng W, Sun X, Chu X, Jiang C, Wang Y, Zhu D, Bi Y. Prolactin improves hepatic steatosis via CD36 pathway. J Hepatol. 2018 Jun;68(6):1247-1255. doi: 10.1016/j.jhep.2018.01.035. Epub 2018 Feb 13.'}]}, 'descriptionModule': {'briefSummary': 'This study focus on the cause of obesity and impacts of bariatric surgery on it.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obesity patients and controls', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Body mass index ≥18 kg/m2\n2. already received bariatric surgery or abdonimal surgery\n\nExclusion Criteria:\n\n1. acute stroke or acute myocardial infarction in 6 months\n2. autoimmune disease\n3. long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs\n4. pregnancy\n5. consists with other endocrine diseases\n6. acute infection in2 weeks\n7. cancer\n8. use of antibiotics in 3 months\n9. chronic digestive inflammations 9'}, 'identificationModule': {'nctId': 'NCT03296605', 'briefTitle': 'Development of Obesity and Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}, 'officialTitle': 'Impacts of Bariatric Surgery on Obesity in China', 'orgStudyIdInfo': {'id': 'AF/SC-08/02.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Obesity', 'description': 'Patients with obesity already received bariatric surgery'}, {'label': 'Healthy control', 'description': 'Volunteers with normal body weight and already received abdominal surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Zhu DaLong', 'investigatorAffiliation': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School'}}}}