Ignite Creation Date:
2025-12-25 @ 3:49 AM
Ignite Modification Date:
2025-12-26 @ 2:36 AM
Study NCT ID:
NCT00965302
Status:
TERMINATED
Last Update Posted:
2023-04-25
First Post:
2009-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'Investigator did not submit an annual continuation report with the Institutional Review Board and the study was officially removed from IRB regulatory oversight on Sep 2014, based on 32 CFR 219.109e. The study officially expired/terminated.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2009-08-24', 'studyFirstSubmitQcDate': '2009-08-24', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes remission', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '1 year'}, {'measure': 'Obstructive sleep apnea remission', 'timeFrame': '1 year'}, {'measure': 'Fasting lipid profile', 'timeFrame': '1 year'}, {'measure': 'c-reactive protein', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Diabetes mellitus, Type 2', 'Sleeve gastrectomy', 'Metabolic surgery'], 'conditions': ['Diabetes Mellitus, Type 2', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '16670131', 'type': 'BACKGROUND', 'citation': "O'Brien PE, Dixon JB, Laurie C, Skinner S, Proietto J, McNeil J, Strauss B, Marks S, Schachter L, Chapman L, Anderson M. Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Ann Intern Med. 2006 May 2;144(9):625-33. doi: 10.7326/0003-4819-144-9-200605020-00005."}, {'pmid': '18996758', 'type': 'BACKGROUND', 'citation': 'Kakoulidis TP, Karringer A, Gloaguen T, Arvidsson D. Initial results with sleeve gastrectomy for patients with class I obesity (BMI 30-35 kg/m2). Surg Obes Relat Dis. 2009 Jul-Aug;5(4):425-8. doi: 10.1016/j.soard.2008.09.009. Epub 2008 Sep 26.'}, {'pmid': '17356932', 'type': 'BACKGROUND', 'citation': 'Lee CM, Cirangle PT, Jossart GH. Vertical gastrectomy for morbid obesity in 216 patients: report of two-year results. Surg Endosc. 2007 Oct;21(10):1810-6. doi: 10.1007/s00464-007-9276-y. Epub 2007 Mar 14.'}, {'pmid': '18212316', 'type': 'BACKGROUND', 'citation': "Dixon JB, O'Brien PE, Playfair J, Chapman L, Schachter LM, Skinner S, Proietto J, Bailey M, Anderson M. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. 2008 Jan 23;299(3):316-23. doi: 10.1001/jama.299.3.316."}, {'pmid': '16925363', 'type': 'BACKGROUND', 'citation': 'Cohen R, Pinheiro JS, Correa JL, Schiavon CA. Laparoscopic Roux-en-Y gastric bypass for BMI < 35 kg/m(2): a tailored approach. Surg Obes Relat Dis. 2006 May-Jun;2(3):401-4, discussion 404. doi: 10.1016/j.soard.2006.02.011.'}]}, 'descriptionModule': {'briefSummary': 'The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension, sleep apnea, c-reactive protein, and fasting lipid profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes mellitus, Type 2\n* Body Mass Index (BMI) 30-34.9\n* Able to understand and comply with study process\n\nExclusion Criteria:\n\n* Pregnancy\n* Prior bariatric surgery\n* Diabetes mellitus, Type 1\n* Renal impairment\n* Cirrhosis or portal hypertension\n* Diabetes secondary to a specific condition\n* Recent internal malignancy (\\<5 years)\n* Recent major vascular event\n* Drug or alcohol dependence\n* Uncontrolled psychiatric disease\n* Crippling cardiopulmonary disease\n* Prohibitive anatomic features (extensive prior surgery, giant paraesophageal hernia)'}, 'identificationModule': {'nctId': 'NCT00965302', 'briefTitle': 'Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients', 'organization': {'class': 'FED', 'fullName': '59th Medical Wing'}, 'officialTitle': 'Sleeve Gastrectomy vs Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients', 'orgStudyIdInfo': {'id': 'FWH20090068H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive medical management of Type 2 DM', 'description': 'Intensive medical management of Type II diabetes will include visits every three months for a year with an endocrinologist, with lifestyle counseling, weight management, regular exercise, and glucose control forming the core of the medical therapy.', 'interventionNames': ['Behavioral: Intensive medical management']}, {'type': 'EXPERIMENTAL', 'label': 'Laparoscopic sleeve gastrectomy', 'description': 'Laparoscopic sleeve gastrectomy is performed as part of a bariatric surgical program emphasizing healthy dietary choices, regular exercise, and glucose control.', 'interventionNames': ['Procedure: Laparoscopic sleeve gastrectomy']}], 'interventions': [{'name': 'Laparoscopic sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic sleeve gastrectomy, also known as vertical sleeve gastrectomy, sleeve gastroplasty, or sleeve gastrectomy, will be performed over a 32 to 40 French sizing bougie.', 'armGroupLabels': ['Laparoscopic sleeve gastrectomy']}, {'name': 'Intensive medical management', 'type': 'BEHAVIORAL', 'description': 'Intensive medical therapy for Diabetes mellitus, Type 2, will include weight management counseling, exercise, glucose control, and healthy dietary choices.', 'armGroupLabels': ['Intensive medical management of Type 2 DM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78236', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Wilford Hall Medical Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Jason M Pfluke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wilford Hall Medical Center, United States Air Force'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '59th Medical Wing', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'Jason M. Pfluke, MD MAJ USAF MC', 'oldOrganization': 'Wilford Hall Medical Center, United States Air Force'}}}}