Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-28 @ 5:09 PM
Study NCT ID:
NCT01913392
Status:
COMPLETED
Last Update Posted:
2019-12-02
First Post:
2013-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Laparoscopic Sleeve Gastrectomy in the Morbidly Obese, Kidney Transplant Candidate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-05-26', 'size': 552098, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-11-14T15:17', 'hasProtocol': False}, {'date': '2013-04-18', 'size': 748527, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-11-27T14:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-27', 'studyFirstSubmitDate': '2013-07-30', 'studyFirstSubmitQcDate': '2013-07-31', 'lastUpdatePostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in the pharmacokinetics of oral immunosuppressive medications due to bariatric surgery, comparing pre-bariatric surgery to 12 months post-operative', 'timeFrame': 'pre-bariatric surgery and 1 year after surgery', 'description': 'Tacrolimus and Mycophenolate AUC 0-24h'}, {'measure': 'degree of weight loss achieved after bariatric surgery in the chronic renal failure patient.', 'timeFrame': 'baseline and every 3 months', 'description': 'weight, BMI and abdominal circumference measures'}, {'measure': 'Evaluate the change in general quality of life score, SF-36', 'timeFrame': 'Baseline and 1 year after bariatric surgery', 'description': 'comparison of the SF score between Baseline and month 3, Baseline and month 6 and Baseline and month 12'}], 'secondaryOutcomes': [{'measure': 'evaluate changes to residual renal function in the pre-dialysis renal transplant candidate', 'timeFrame': 'at baseline versus month 12 post-bariatric surgery', 'description': 'serum creatinine/ urea, sodium, potassium, magnesium, calcium, phosphate and bicarbonate pre surgery and month 12'}, {'measure': 'evaluate the change in the number and dose of medications required to treat co-morbidities including, hypertension, hyperlipidemia and diabetes mellitus', 'timeFrame': 'baseline and 12 month post-bariatric surgery', 'description': 'concommitant medication records at baseline vs month 12'}, {'measure': 'the incidence of complications post-bariatric surgery will be evaluated', 'timeFrame': '1, 6 and 12 months post-bariatric surgery', 'description': 'non serious and serious adverse events collection at Baseline, month 6 and month 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity, Morbid', 'Transplant; Failure, Kidney']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://doi.org/10.1111/ajt.15602', 'label': 'Prospective Study of the Changes in Pharmacokinetics of Immunosuppressive Medications after Laparoscopic Sleeve Gastrectomy'}]}, 'descriptionModule': {'briefSummary': 'A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the potential renal transplant candidate who is denied acceptance due mainly to the morbid obesity.', 'detailedDescription': 'The remaining factor in determining the effectiveness of bariatric surgery in the transplant population will be to study the effect on the pharmacokinetics of immunosuppressive medication, height, weight, BMI, abdominal circumference, blood pressure, Hba1c , average daily insulin requirements, lipid profile, TSH, 24h urine creatinine clearance and the SF-36 Quality of life questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'morbidly obese, kidney transplant candidate with stage IV or V chronic renal disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult (\\>18 years)\n* stage IV and V chronic renal disease (glomerular filtration rate \\< 30 ml/min,\n* body mass index (BMI) of greater than 40 kg/m2 or \\> 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes\n\nExclusion Criteria:\n\n* medically unfit for surgical intervention\n* previous gastric or intestinal surgery\n* active gastric disease\n* pregnancy or lactation\n* known intolerance to tacrolimus or mycophenolic acid\n* awaiting potential multi-organ transplantation\n* active infection'}, 'identificationModule': {'nctId': 'NCT01913392', 'briefTitle': 'Effect of Laparoscopic Sleeve Gastrectomy in the Morbidly Obese, Kidney Transplant Candidate', 'organization': {'class': 'OTHER', 'fullName': 'Maisonneuve-Rosemont Hospital'}, 'officialTitle': 'Prospective, Clinical Study of the Effect of Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, on the Pharmacokinetics of Immunosuppressive Drugs in the Morbidly Obese, Kidney Transplant Candidate', 'orgStudyIdInfo': {'id': '2014-530-13022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'morbidly obese, chronic renal disease', 'description': 'adult patients (\\> 18 years) who have stage 4 or 5 chronic renal disease (CrCl \\< 30 ml/min) who are being considered for possible future kidney transplantation. The study inclusion criteria are an indication for laparoscopic sleeve gastrectomy (BMI \\> 40 kg/m2, or BMI \\> 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes)', 'interventionNames': ['Procedure: laparoscopic sleeve gastrectomy']}], 'interventions': [{'name': 'laparoscopic sleeve gastrectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['morbidly obese, chronic renal disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'MaisonneuveRH', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Gabriel Chan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maisonneuve-Rosemont Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian surgical research fund', 'class': 'UNKNOWN'}, {'name': 'Astellas Pharma Canada, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Transplant and general surgeon', 'investigatorFullName': 'Gabriel Chan, Md', 'investigatorAffiliation': 'Maisonneuve-Rosemont Hospital'}}}}