Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02732535
Status:
UNKNOWN
Last Update Posted:
2016-04-14
First Post:
2015-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural Killer (NK) Cells Following Bariatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C566492', 'term': 'Natural Killer Cell Deficiency, Familial Isolated'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D005763', 'term': 'Gastroenterostomy'}, {'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-13', 'studyFirstSubmitDate': '2015-12-02', 'studyFirstSubmitQcDate': '2016-04-04', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine Natural Killer (NK) cell phenotype and alterations prior and following Bariatric surgery', 'timeFrame': '1 year', 'description': 'NK cells are through to play role in modulating fibrogenesis. They exert an anti-fibrotic effects by Killing activated hepatic stellate Cells; the major cells responsible for fibrosis.\n\nNK cells activations are crucial step in inhibiting liver fibrosis. Therefore, their functions are thought to be affected in Obese patients.\n\nOur aim is to investigate changes in peripheral Blood NK cells by detecting their cytotoxicity potentials by CD107a (LAMP-1; Lysosomal-associated membrane protein 1) as a marker for activation and analyze them by flow-cytometry.\n\nPeripheral Blood NK cells will be obtained from obese patients prior to Bariatric surgery and following 3 months, 6 months and 12 months of the surgery.'}], 'secondaryOutcomes': [{'measure': 'To assess the fibrosis downstaging by fibroscan prior and following Bariatric surgery', 'timeFrame': '1 year', 'description': 'The liver fibrosis can be assess by fibroscan and scored from 0 to 4 . all the participants will be assessed by fibroscan prior an 3,6,12 month postoperative to determine the degree of down staging of liver fibrosis'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Natural Killer Cell Deficiency, Familial Isolated']}, 'descriptionModule': {'briefSummary': 'This study will determine the role of the NK cells before and after bariatric surgery. The investigators selected patients with NAFLD.\n\nA Fibroscan evaluation will be assessed as a new modality to evaluate liver fibrosis.', 'detailedDescription': 'All morbidly obese patients who are candidates for a bariatric procedure in the investigators institution who has a fatty liver in their routine preoperative US will undergo a fibroscan to assess the degree of liver fibrosis preoperatively in addition to a blood sample that will be withdrawn from those participants to isolate the NK cells and to assess their activities by the assessment of the active form of NK cells (CD107a) using the spectrometry (FACS) analysis.\n\nThe investigators will also collect other clinical data including comorbidities (hypertension, diabetes mellitus and hyperlipidemia) in addition to the following routine blood test( complete blood count, creatinine, urea, International normalized ratio, liver function test, HBa1C, cholesterol, HDL, LDL, triglycerides, vitamin D, vitamin B12, potassium, sodium, albumin, bilirubin, C- reactive protein, iron, ferritin and transferrin).\n\nAll of the above mentioned tests including the NK cells and the fibroscan will be examined for all participants in 3, 6, 12 months postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'obese patient with BMI above 30 with comorbidity or BMI above 35 with or without comorbidity, that have evidence of hepatic fibrosis on the routine preoperative US', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age from 18-65\n* body mass index above 30 with comorbidity or above 35 with or without comorbidity\n* evidence of hepatic fibrosis in routine preoperative US\n\nExclusion Criteria:\n\n* patient with known other liver disease such as autoimmune or alcoholic hepatitis\n* patient that take hepatotoxic medication or hormonal treatment\n* active alcohol abuse above 20 gram per day\n* Drug abuse\n* patient refusal\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02732535', 'briefTitle': 'Natural Killer (NK) Cells Following Bariatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'The Natural Killer Cells Regulatory Role Against Hepatic Fibrosis Following Bariatric Surgery', 'orgStudyIdInfo': {'id': '0298-15-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'sleeve gastrectomy , roux-en-y gastric bypass', 'type': 'PROCEDURE', 'description': 'laparoscopic sleeve gastrectomy or laparoscopic gastric bypass'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12000', 'city': 'Jerusalem', 'state': 'Israel', 'country': 'Israel', 'facility': 'Hadassah Medical Organization,Jerusalem,Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'overallOfficials': [{'name': 'Abed Khalaileh, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'israel ministrty of health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}