Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT03915158
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2019-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Status of Patients Before and After Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole Blood \\< 20 mL'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Nutritional status', 'timeFrame': 'pre-surgery and 6 months after surgery', 'description': 'Blood sample will be collected and used to determine nutritional status which will measured by laboratory biochemical test.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nutritional Status']}, 'referencesModule': {'references': [{'pmid': '32638247', 'type': 'DERIVED', 'citation': 'Lin CH, Liao WL, Wu CC, Shaw HM, Hsu WL, Lu YC, Yang JS, Huang CK, Chao PM. Nutritional Status of Obese Taiwanese Before Bariatric-Metabolic Surgery and Their Serum 25-Hydroxyvitamin D Concentrations for Maximal Suppression of Parathyroid Hormone. Obes Surg. 2020 Oct;30(10):3940-3946. doi: 10.1007/s11695-020-04759-y. Epub 2020 Jul 8.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed at evaluating the nutritional status of vitB1, B2, B12, folate, A, D, E, Ca, Fe, Zn, Cu, and Se prior- and post- (6-Mo) the sleeve gastrectomy operation.', 'detailedDescription': 'Bariatric surgery (BS) is the most effective treatment for severe obesity and comorbidities. Among varieties of BS techniques, sleeve gastrectomy (SG) has gained in popularity worldwide. SG is a procedure involved mainly restriction combined slightly with malabsorption (deficiency in intrinsic factors for vitamin B12 absorption). Considering most patients usually have more than one micronutrients deficiency prior the surgery, the aggravated nutritional status is one of post-surgical concerns. For nutrition management, individualized biochemical assessment for micronutrients is highly recommended in guideline, but is seldom been implanted. Instead, a routine supplementation for vitamins/minerals for postoperative patients is practiced in Taiwan. This study aimed at evaluating the nutritional status of vitB1, B2, B12, folate, A, D, E, Ca, Fe, Zn, Cu, and Se prior- and post- (6-Mo) the SG operation. Subjects (n=70-100) will be recruited from patients of Body Science \\& Metabolic Disorders, International BMI Medical Center of CMUH. The inclusion criteria are Han Chinese, 18-65 years old, and BMI\\>30 who have arranged for SG operation. Written informed consent will be obtained from participants. Anthropometric data, blood samples, food (including supplements) records and medical history will be collected during the study period. We foresee this study may, not only achieve a personalized dietary plan, but also contribute to indigenous data regarding micronutrient status of obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects will be recruited from patients of Body Science \\& Metabolic Disorders International Medical Center.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Han Chinese and Taiwanese\n* BMI more than or equal to 27.5\n* Surgery type is sleeve gastrectomy\n\nExclusion Criteria:\n\n* Kidney dysfunction\n* Mental illness\n* Severe eating disorders\n* Alcohol or drug abuse\n* Stomach ulcers\n* Redo bariatric surgery'}, 'identificationModule': {'nctId': 'NCT03915158', 'briefTitle': 'Nutritional Status of Patients Before and After Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Biochemical Evaluations of Nutritional Status of Patients Before and After Bariatric and Metabolic Surgery', 'orgStudyIdInfo': {'id': 'CMUH107-REC1-144'}}, 'armsInterventionsModule': {'interventions': [{'name': 'bariatric surgery', 'type': 'PROCEDURE', 'description': 'sleeve gastrectomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40402', 'city': 'Taichung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Pei-Min Chao, PhD', 'role': 'CONTACT', 'email': 'pmchao@mail.cmu.edu.tw', 'phone': '+886-4-22053366', 'phoneExt': '7509'}], 'facility': 'China Medical University', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'Pei-Min Chao, PhD', 'role': 'CONTACT', 'email': 'pmchao@mail.cmu.edu.tw', 'phone': '+886-4-22053366', 'phoneExt': '7509'}], 'overallOfficials': [{'name': 'Pei-Min Chao, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nutrition, China Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}