Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-04-23 @ 5:19 AM
Study NCT ID:
NCT02128802
Status:
COMPLETED
Last Update Posted:
2025-03-10
First Post:
2014-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obesity Surgery and Kidney Transplant for Patients With Obesity and Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}, {'id': 'D061217', 'term': 'Weight Reduction Programs'}], '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'}, {'id': 'D006293', 'term': 'Health Promotion'}, {'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2014-04-23', 'studyFirstSubmitQcDate': '2014-04-29', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Prograf dosing', 'timeFrame': '5 years', 'description': 'This outcome will assess the amount of prograf required for therapeutic levels'}], 'primaryOutcomes': [{'measure': 'Ability to reach medical suitability for renal transplant within 18 months after initiating treatment and the change and trajectory of health-related quality of life (HRQOL)', 'timeFrame': '18 months', 'description': 'Outcomes will be measured based on weight loss and a variety of validated surveys and questionnaires to measure HRQOL'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': '5 years', 'description': 'Number of patients who die from any cause'}, {'measure': 'Weight loss', 'timeFrame': '5 years', 'description': 'Amount of weight lost at various points over the study period'}, {'measure': 'Surgical outcomes', 'timeFrame': '5 years', 'description': 'Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection.'}, {'measure': 'Development or regression of diabetes', 'timeFrame': '5 years', 'description': 'Including but not limited to start of stop of insulin therapy, amount of insulin required, and start or stop of or cal medications.'}, {'measure': 'Development or regression of other comorbidities', 'timeFrame': '5 years', 'description': 'Development or regression of other diseases including but not limited to hypertension, coronary artery disease, and skin infections.'}, {'measure': 'Health care utilization', 'timeFrame': '5 years', 'description': 'This outcome measure includes but is not limited to the amount of money spent on health care, total hospitalization, days of hospitalization, and procedures required.'}, {'measure': 'Nutritional status', 'timeFrame': '5 years', 'description': 'This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake.'}, {'measure': 'Hormonal and metabolic status', 'timeFrame': '5 years', 'description': 'This outcome includes but is not limited to measurement of protein catabolism, creatinine clearance, and serum prealbumin. In addition, protein and iron metabolism will be measured using serum albumin, transferrin and ferritin. Glucose metabolism will be measured by glucose and insulin levels. regression of the disease. Lipid metabolism will be assessed with triglyceride levels, very-low density lipoproteins, and cholesterol. Micronutrient levels will be measured with vitamin D, thiamin, B12, and folate.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Renal failure', 'Gastric bypass'], 'conditions': ['Severe Obesity', 'Renal Failure']}, 'descriptionModule': {'briefSummary': 'Gastric Bypass followed by renal transplantation is superior to medical management followed by renal transplant for patients with severe obesity and renal failure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Body mass index 40-55 kg/m2\n* Age less than 60 years\n* Available support person\n* Adequate insurance\n* All other criteria required for renal transplantation\n\nExclusion Criteria:\n\n* Schizophrenia\n* Bipolar disorder\n* Crohn's disease\n* Human Immunodeficiency Virus\n* Cirrhosis\n* Prior weight loss surgery\n* Prior mesh hernia repair\n* Prior anti-reflux surgery\n* Inability to walk 200 feet\n* Significant coronary disease\n* Significant lung disease - Fixed expiratory volume 1 less than 75% or on oxygen\n* Addiction to alcohol or drugs\n* Inability to quit smoking\n* Jehovah's witness\n* Non-compliance with dialysis regimen\n* Previous renal transplant\n* Non-English speaking"}, 'identificationModule': {'nctId': 'NCT02128802', 'briefTitle': 'Obesity Surgery and Kidney Transplant for Patients With Obesity and Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Weight Reduction Surgery Followed by Kidney Transplantation for Patients With Class III Obesity and Renal Failure', 'orgStudyIdInfo': {'id': '130912'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Surgical Gastric Bypass', 'description': 'Patients will undergo surgical gastric bypass according to standard institutional protocols', 'interventionNames': ['Procedure: Gastric Bypass']}, {'type': 'EXPERIMENTAL', 'label': 'Medical Weight Loss Management', 'description': 'Patients will receive best practices medical management for weight loss under current institutional protocols', 'interventionNames': ['Other: Weight Loss Program']}], 'interventions': [{'name': 'Gastric Bypass', 'type': 'PROCEDURE', 'armGroupLabels': ['Surgical Gastric Bypass']}, {'name': 'Weight Loss Program', 'type': 'OTHER', 'armGroupLabels': ['Medical Weight Loss Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Seth Karp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Seth Karp', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}