Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT02697695
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2016-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Inflammation After Obesity 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-29', 'studyFirstSubmitDate': '2016-02-20', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic inflammation', 'timeFrame': 'one day preoperatively, and 1 month, 3 month, 6 month and up to 12 month postoperatively', 'description': 'the changing of leucocytes in /nl after obesity surgery'}], 'secondaryOutcomes': [{'measure': 'Fatty liver index', 'timeFrame': 'one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively', 'description': 'the changing of fatty liver index after obesity surgery'}, {'measure': 'Liver enzymes', 'timeFrame': 'one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively', 'description': 'the changing of GOT in U/l, GPT in U/l, GGT in U/l, AP in U/l after obesity surgery'}, {'measure': 'Body Mass Index (BMI) in kg/m²', 'timeFrame': 'one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively', 'description': 'the changing of BMI in kg/m² before and after obesity surgery'}, {'measure': 'weight in kg', 'timeFrame': 'one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively', 'description': 'the changing of weight before and after obesity surgery'}, {'measure': 'waist circumference', 'timeFrame': 'one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively', 'description': 'the changing of waist circumference in cm before and after obesity surgery'}, {'measure': 'HbA1c', 'timeFrame': 'one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively', 'description': 'the changing of HbA1c in % and after obesity surgery'}, {'measure': 'Chronic inflammation II', 'timeFrame': 'one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively', 'description': 'the changing of c-reactive protein in mg/l after obesity surgery'}, {'measure': 'Acute inflammation', 'timeFrame': 'one day preoperatively and one and four days postoperatively', 'description': 'the changing of c-reactive protein in mg/l after obesity surgery'}, {'measure': 'Acute inflammation II', 'timeFrame': 'one day preoperatively and one and four days postoperatively', 'description': 'the changing of leucocytes in /nl after obesity surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic inflammation', 'fatty liver index'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '17167474', 'type': 'RESULT', 'citation': 'Hotamisligil GS. Inflammation and metabolic disorders. Nature. 2006 Dec 14;444(7121):860-7. doi: 10.1038/nature05485.'}, {'pmid': '19390527', 'type': 'RESULT', 'citation': 'Nijhuis J, Rensen SS, Slaats Y, van Dielen FM, Buurman WA, Greve JW. Neutrophil activation in morbid obesity, chronic activation of acute inflammation. Obesity (Silver Spring). 2009 Nov;17(11):2014-8. doi: 10.1038/oby.2009.113. Epub 2009 Apr 23.'}, {'pmid': '26865887', 'type': 'RESULT', 'citation': 'Morshed G, Fathy SM. Impact of post-laparoscopic sleeve gastrectomy weight loss on C-reactive protein, lipid profile and CA-125 in morbidly obese women. Wideochir Inne Tech Maloinwazyjne. 2016 Jan;10(4):521-6. doi: 10.5114/wiitm.2015.56480. Epub 2015 Dec 15.'}, {'pmid': '15864338', 'type': 'RESULT', 'citation': 'Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. doi: 10.1172/JCI25102.'}, {'pmid': '15599400', 'type': 'RESULT', 'citation': 'Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.'}, {'pmid': '29876839', 'type': 'DERIVED', 'citation': 'Chiappetta S, Schaack HM, Wolnerhannsen B, Stier C, Squillante S, Weiner RA. The Impact of Obesity and Metabolic Surgery on Chronic Inflammation. Obes Surg. 2018 Oct;28(10):3028-3040. doi: 10.1007/s11695-018-3320-y.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the impact of obesity surgery on chronic inflammation.', 'detailedDescription': 'A retrospective study to compare the impact of laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en Y- gastric bypass (LRYGB) and laparoscopic omega-loop gastric bypass (LOLGB) on chronic inflammation and metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent LSG, LRYGB, LOLGB due to obesity and/or metabolic syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 35kg/m² and obesity-related disease or BMI \\> 40kg/m²\n\nExclusion Criteria:\n\n* acute inflammation during laboratory examination'}, 'identificationModule': {'nctId': 'NCT02697695', 'briefTitle': 'Chronic Inflammation After Obesity Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Sana Klinikum Offenbach'}, 'officialTitle': 'Impact of Obesity and Metabolic Surgery on Chronic Inflammation', 'orgStudyIdInfo': {'id': 'FF 145/2015'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'laparoscopic sleeve gastrectomy', 'description': 'patients who underwent laparoscopic sleeve gastrectomy (LSG) due to obesity and/or metabolic syndrome', 'interventionNames': ['Other: Laboratory Examination']}, {'label': 'laparoscopic Roux-en-Y- gastric bypass', 'description': 'patients who underwent laparoscopic Roux-en-Y- gastric bypass (LRYGB) due to obesity and/or metabolic syndrome', 'interventionNames': ['Other: Laboratory Examination']}, {'label': 'laparoscopic omega-loop gastric bypass', 'description': 'patients who underwent laparoscopic omega-loop gastric bypass (LOLGB) due to obesity and/or metabolic syndrome', 'interventionNames': ['Other: Laboratory Examination']}], 'interventions': [{'name': 'Laboratory Examination', 'type': 'OTHER', 'description': 'Laboratory Examination before, 1 month, 3 month, 6 month and up to 12 month after LSK, LRNYGB, LOLGB', 'armGroupLabels': ['laparoscopic Roux-en-Y- gastric bypass', 'laparoscopic omega-loop gastric bypass', 'laparoscopic sleeve gastrectomy']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Rudolf Weiner, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sana Klinikum Offenbach', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Sonja Chiappetta', 'investigatorFullName': 'Sonja Chiappetta, MD', 'investigatorAffiliation': 'Sana Klinikum Offenbach'}}}}