Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-03-23 @ 7:32 AM
Study NCT ID:
NCT00558532
Status:
WITHDRAWN
Last Update Posted:
2016-06-13
First Post:
2007-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, plasma, fat tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Investigator Retired.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-10', 'studyFirstSubmitDate': '2007-11-14', 'studyFirstSubmitQcDate': '2007-11-14', 'lastUpdatePostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Omega-3 Fatty acid levels in whole blood, plasma and abdominal fat sample', 'timeFrame': 'Within 3 months of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Morbid obesity', 'Omega-3 fatty acid levels'], 'conditions': ['Morbid Obesity', 'Cardiovascular Disease', 'Fatty Acid Levels']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the concentration of omega-3 fatty acids in plasma, blood and abdominal fat before and after bariatric surgery to provide guidance for future studies.', 'detailedDescription': 'The omega-3 fatty acids are essential for human growth, development and well-being. Numerous studies have shown that a relatively high intake of the omega-3 fatty acids are beneficial in brain and visual development, psychiatric disorders, rheumatic disorders, inflammatory responses and cardiovascular disease. As an example, low levels of tissue omega-3 fatty acids are associated with a markedly higher rate of death from cardiac causes compared to patients with relatively high concentrations of the omega-3 fatty acids. Obese patients often have an unhealthy dietary intake and evidence of increased inflammatory processes. After a gastric bypass patients will have decreased absorption of fats from the gastrointestinal tract and may become fatty acid deficient. While gastric bypass may decrease death from cardiovascular disease in morbidly obese patients, cardiovascular disease is still the most common cause of death after a gastric bypass. There are numerous nutritional deficiencies which occur after gastric bypass and many of these are well documented. However, there are no data concerning the plasma and tissue levels of omega-3 fatty acids in morbidly obese patients either before or after operation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients undergoing an operation for morbid obesity will be candidates for inclusion in the study as will all candidates who are undergoing abdominoplasty or other abdominal operations post bariatric surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical group candidates must be undergoing surgery for morbid obesity, abdominoplasty or other abdominal operation.\n* Must have adequate venous access.\n\nExclusion Criteria:\n\n* Insufficient venous access'}, 'identificationModule': {'nctId': 'NCT00558532', 'briefTitle': 'Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment', 'orgStudyIdInfo': {'id': '07-66'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical', 'description': 'Those subjects undergoing bariatric surgery or abdominal surgery following a previous bariatric surgery.', 'interventionNames': ['Procedure: Bariatric Surgery']}, {'label': 'Control', 'description': 'Volunteers who have dietary habits similar to the subjects.'}], 'interventions': [{'name': 'Bariatric Surgery', 'type': 'PROCEDURE', 'description': 'Open roux-en-Y gastric bypass, open banded sleeve gastrectomy, abdominoplasty, other abdominal surgery', 'armGroupLabels': ['Surgical']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'J. W. Alexander, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emeritus', 'investigatorFullName': 'J. Wesley Alexander', 'investigatorAffiliation': 'University of Cincinnati'}}}}