Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT01073020
Status:
COMPLETED
Last Update Posted:
2021-06-28
First Post:
2010-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015390', 'term': 'Gastric Bypass'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], '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': 'D013505', 'term': 'Digestive System Surgical Procedures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mary.elizabeth.patti@joslin.harvard.edu', 'phone': '617 309 1966', 'title': 'Mary Elizabeth Patti MD', 'organization': 'Joslin Diabetes Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Small sample size limits generalizability. Study performed at a single academic medical center. Duration of diabetes and insulin use, as proxies for β-cell function, were not inclusion or exclusion criteria.\n\nLong-term durability of beneficial effects of reducing weight and HbA1c could not be evaluated after 3 years.\n\nNewer bariatric surgical procedures, e.g. sleeve gastrectomy, were not studied.'}}, 'adverseEventsModule': {'timeFrame': '3 years', 'description': 'Adverse events (AE), including all-cause mortality, serious, and other adverse events were monitored in all participants, and information is included in this report. For those who were lost to followup, AE were recorded up to the timepoint of loss to followup. The total number of participants indicated is the number who completed 3 years of followup, and thus for whom AE monitoring was complete for the 3 year study.', 'eventGroups': [{'id': 'EG000', 'title': 'Laparoscopic Adjustable Gastric Band Surgery', 'description': 'Surgical Implantation of Allergan Adjustable Gastric Band (Device)', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG001', 'title': 'Intensive Medical Diabetes and Weight Management: Band Group', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Roux-en-Y Gastric Bypass (RYGB) Surgery', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG003', 'title': 'Intensive Medical Diabetes and Weight Management: RYGB Group', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'seriousEvents': [{'term': 'sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'hospitalization for diabetes management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'coronary bypass graft or stent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'cardiac arrest - survived', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'syringomyelia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'bariatric surgery revisions and complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': "Erb's palsy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'cancer', 'notes': '1 prostate (IMWM-band requiring 2 surgical procedures), 1 breast (RYGB)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'orthopedic procedures', 'notes': 'laminectomy (IMWM-band), hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'renal', 'notes': 'surgical repair for urinary incontinence (IMWM-band), acute kidney injury (RYGB), nephrolithiasis (RYGB), urinary tract infection (RYGB)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'congestive heart failure hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'supraventricular arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'psychiatric hospitalizations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'panniculectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fasting Plasma Glucose <126 mg/dL and HbA1c < 6.5% at Three Years of Follow-up.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LAGB', 'description': 'Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device)\n\nParticipants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG001', 'title': 'Intensive Medical Diabetes & Weight Management (LAGB Grp)', 'description': 'Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG002', 'title': 'RYGB', 'description': 'Roux-en-Y Gastric Bypass (Surgery)\n\nParticipants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG003', 'title': 'Intensive Medical Diabetes & Weight Management (RYGB Grp)', 'description': 'Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.60', 'groupIds': ['OG000', 'OG001'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.08', 'estimateComment': 'Estimation parameter is the difference between the proportion of patients in the LAGB group vs. proportion of patients in the Intensive Medical Diabetes \\& Weight Management (LAGB Grp) who achieved the primary outcome.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.005', 'groupIds': ['OG002', 'OG003'], 'paramType': 'proportion', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.42', 'estimateComment': 'Estimation parameter is the difference between the proportion of patients in the RYGB group vs. proportion of patients in the Intensive Medical Diabetes \\& Weight Management (RYGB Grp) who achieved the primary outcome.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': '3 years', 'description': 'The primary outcome variable of both parallel trials will be the percent of patients attaining glycemic control (defined as fasting plasma glucose \\< 126 mg/dL and HbA1c \\< 6.5%) at three years of follow-up.', 'unitOfMeasure': '% of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients not analyzed include: 7 of 23 in LAGB (4 withdrew consent before intervention,1 determined to not be a surgical candidate before intervention, and 2 withdrew consent between 1 and 3 years); 5 of 22 in IMWM (LAGB Grp) (4 withdrew consent, 1 death); 3 of 22 in the RYGB group (1 withdrew consent; 1 breast cancer diagnosis and 1 psychiatric illness pre-intervention); 2 of 21 IMWM (RYGB Grp) withdrew consent before intervention.'}, {'type': 'SECONDARY', 'title': 'Glycemic Control, as Measured by Hemoglobin A1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LAGB', 'description': 'Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device)\n\nParticipants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG001', 'title': 'Intensive Medical Diabetes & Weight Management (LAGB Grp)', 'description': 'Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG002', 'title': 'RYGB', 'description': 'Roux-en-Y Gastric Bypass (Surgery)\n\nParticipants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG003', 'title': 'Intensive Medical Diabetes & Weight Management (RYGB Grp)', 'description': 'Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'groupId': 'OG000', 'lowerLimit': '-1.6', 'upperLimit': '-0.0'}, {'value': '0.2', 'groupId': 'OG001', 'lowerLimit': '-0.6', 'upperLimit': '1.0'}, {'value': '-1.8', 'groupId': 'OG002', 'lowerLimit': '-2.4', 'upperLimit': '-1.2'}, {'value': '-0.4', 'groupId': 'OG003', 'lowerLimit': '-1.1', 'upperLimit': '0.3'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'estimateComment': 'Estimation parameter is the difference between the change from baseline in HbA1c in the LAGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \\& Weight Management (LAGB Grp), adjusted for baseline HbA1c.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'estimateComment': 'Estimation parameter is the difference between the change from baseline in HbA1c in the RYGB group vs. change from baseline in HbA1c in the Intensive Medical Diabetes \\& Weight Management (RYGB Grp), adjusted for baseline HbA1c.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'All participants had type 2 diabetes. Long-term diabetes control is typically evaluated in both clinical and research settings using the measurement of Hemoglobin A1c (a measure of glycated hemoglobin, proportional to average glucose levels over approximately 3 months). This endpoint (hemoglobin A1c) was measured at 3 years after intervention. Reported values are changes from baseline derived from the mixed effects model analysis, adjusted for baseline.', 'unitOfMeasure': 'Percent', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients who had at least one post-randomization visit (modified intention to treat).'}, {'type': 'SECONDARY', 'title': 'Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LAGB', 'description': 'Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device)\n\nParticipants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG001', 'title': 'Intensive Medical Diabetes & Weight Management (LAGB Grp)', 'description': 'Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG002', 'title': 'RYGB', 'description': 'Roux-en-Y Gastric Bypass (Surgery)\n\nParticipants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG003', 'title': 'Intensive Medical Diabetes & Weight Management (RYGB Grp)', 'description': 'Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.9', 'groupId': 'OG000', 'lowerLimit': '-5.2', 'upperLimit': '-2.6'}, {'value': '-1.7', 'groupId': 'OG001', 'lowerLimit': '-3.0', 'upperLimit': '0.4'}, {'value': '-8.7', 'groupId': 'OG002', 'lowerLimit': '-10.3', 'upperLimit': '-7.1'}, {'value': '-4.1', 'groupId': 'OG003', 'lowerLimit': '-8.8', 'upperLimit': '0.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'estimateComment': 'Estimation parameter is the difference between the change from baseline in BMI in the LAGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \\& Weight Management (LAGB Grp), adjusted for baseline BMI.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.6', 'estimateComment': 'Estimation parameter is the difference between the change from baseline in BMI in the RYGB group vs. change from baseline in BMI in the Intensive Medical Diabetes \\& Weight Management (RYGB Grp), adjusted for baseline BMI.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'Change in body mass index 3 years after intervention', 'unitOfMeasure': 'kg/m^2', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized patients who had at least one post-randomization visit (modified intention to treat).'}, {'type': 'SECONDARY', 'title': 'Cardiovascular Risk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'LAGB', 'description': 'Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device)\n\nParticipants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG001', 'title': 'Intensive Medical Diabetes & Weight Management (LAGB Grp)', 'description': 'Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG002', 'title': 'RYGB', 'description': 'Roux-en-Y Gastric Bypass (Surgery)\n\nParticipants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'OG003', 'title': 'Intensive Medical Diabetes & Weight Management (RYGB Grp)', 'description': 'Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '2.8'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '4.2'}, {'value': '-2.5', 'groupId': 'OG002', 'lowerLimit': '-4.3', 'upperLimit': '-0.7'}, {'value': '0.1', 'groupId': 'OG003', 'lowerLimit': '-2.0', 'upperLimit': '2.1'}]}]}], 'analyses': [{'pValue': '0.81', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'estimateComment': 'Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in LAGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \\& Weight Management (LAGB Grp), adjusted for baseline CHD risk.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.009', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'estimateComment': 'Estimation parameter is the difference between change from baseline in CHD risk over 10 yrs. in RYGB group vs. change from baseline in CHD risk over 10 yrs. in Intensive Medical Diabetes \\& Weight Management (RYGB Grp), adjusted for baseline CHD risk.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '3 years', 'description': 'UKPDS risk of coronary heart disease, reported as change from baseline', 'unitOfMeasure': 'percent likelihood of event in next 10 y', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who had at least one post-randomization visit were analyzed (modified intention to treat).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Laparoscopic Adjustable Gastric Band (LAGB)', 'description': 'Laparoscopic Adjustable Gastric Band (LAGB): Allergan Adjustable Gastric Band (Device)\n\nParticipants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)'}, {'id': 'FG001', 'title': 'Intensive Medical Diabetes & Weight Management (LAGB Grp)', 'description': 'Participants were randomized to LAGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)'}, {'id': 'FG002', 'title': 'RYGB', 'description': 'Roux-en-Y Gastric Bypass (Surgery)\n\nParticipants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why WAIT? Program)'}, {'id': 'FG003', 'title': 'Intensive Medical Diabetes & Weight Management (RYGB Grp)', 'description': 'Participants were randomized to RYGB vs. an intensive medical diabetes and weight management program (Why Wait? Program)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Patients will be recruited from the Joslin Diabetes Center and Partners Healthcare. All patients with type 2 diabetes (T2DM) attending the Brigham and Women's Hospital (BWH) Bariatric Surgery Program orientation sessions (\\>1200 subjects/year) will be presented with this trial as an option. Recruitment will also be from the \\>13,000 T2DM patients who receive their medical care at Joslin Diabetes Center or the Partners Healthcare Primary Care Network.", 'preAssignmentDetails': 'After initial contact, patients will undergo the following: 1) Telephone screening (review inclusion and exclusion criteria, description of interventions), 2) Attend clinical trial orientation session (detailed description of interventions, protocol, procedures, surgical clearance, nutritional evaluation, risks, benefits), 3) Medical and surgical screening visit (sign informed consent, screening lab tests, history and physical, psychological evaluation for bariatric surgery, exercise clearance).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Laparoscopic Adjustable Gastric Band (LAGB)', 'description': 'Laparoscopic Adjustable Gastric Band: Allergan Adjustable Gastric Band (Device)'}, {'id': 'BG001', 'title': 'Intensive Medical Diabetes & Weight Management (LAGB Group)', 'description': 'Intensive Medical Diabetes \\& Weight Management: Intensive Medical Diabetes \\& Weight Management (LAGB Group)\n\nThis group selected band as preferred surgery, but were randomized to medical management.'}, {'id': 'BG002', 'title': 'RYGB', 'description': 'Roux-en-Y Gastric Bypass (Surgery)'}, {'id': 'BG003', 'title': 'Intnnsive Medical Diabetes and Weight Management (RYGB Group)', 'description': 'Intensive Medical Diabetes \\& Weight Management: Intensive Medical Diabetes \\& Weight Management (RYGB Group)\n\nThis group selected RYGB as preferred surgery, but were randomized to medical management.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.1', 'spread': '12.1', 'groupId': 'BG000'}, {'value': '51.4', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '50.7', 'spread': '7.6', 'groupId': 'BG002'}, {'value': '52.6', 'spread': '4.3', 'groupId': 'BG003'}, {'value': '51.4', 'spread': '8.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants first selected whether they preferred gastric band or RYGB. After consent, they were randomized to either surgery or intensive medical diabetes and weight management. This resulted in 2 independent substudies, one of which compared band to its corresponding intensive medical diabetes and weight management group, and one of which compared RYGB to its corresponding intensive medical diabetes and weight management group..'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-01', 'studyFirstSubmitDate': '2010-02-16', 'resultsFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2010-02-19', 'lastUpdatePostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-08', 'studyFirstPostDateStruct': {'date': '2010-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting Plasma Glucose <126 mg/dL and HbA1c < 6.5% at Three Years of Follow-up.', 'timeFrame': '3 years', 'description': 'The primary outcome variable of both parallel trials will be the percent of patients attaining glycemic control (defined as fasting plasma glucose \\< 126 mg/dL and HbA1c \\< 6.5%) at three years of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Glycemic Control, as Measured by Hemoglobin A1c', 'timeFrame': '3 years', 'description': 'All participants had type 2 diabetes. Long-term diabetes control is typically evaluated in both clinical and research settings using the measurement of Hemoglobin A1c (a measure of glycated hemoglobin, proportional to average glucose levels over approximately 3 months). This endpoint (hemoglobin A1c) was measured at 3 years after intervention. Reported values are changes from baseline derived from the mixed effects model analysis, adjusted for baseline.'}, {'measure': 'Body Mass Index', 'timeFrame': '3 years', 'description': 'Change in body mass index 3 years after intervention'}, {'measure': 'Cardiovascular Risk', 'timeFrame': '3 years', 'description': 'UKPDS risk of coronary heart disease, reported as change from baseline'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Type 2 Diabetes Mellitus', 'Obesity', 'Lifestyle', 'Bariatric Surgery', 'Laparoscopic Adjustable Gastric Band', 'Laparoscopic Roux-en-Y Gastric Bypass'], 'conditions': ['Type 2 Diabetes Mellitus', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '21357363', 'type': 'BACKGROUND', 'citation': 'Lautz D, Halperin F, Goebel-Fabbri A, Goldfine AB. The great debate: medicine or surgery: what is best for the patient with type 2 diabetes? Diabetes Care. 2011 Mar;34(3):763-70. doi: 10.2337/dc10-1859. No abstract available.'}, {'pmid': '24899464', 'type': 'RESULT', 'citation': 'Halperin F, Ding SA, Simonson DC, Panosian J, Goebel-Fabbri A, Wewalka M, Hamdy O, Abrahamson M, Clancy K, Foster K, Lautz D, Vernon A, Goldfine AB. Roux-en-Y gastric bypass surgery or lifestyle with intensive medical management in patients with type 2 diabetes: feasibility and 1-year results of a randomized clinical trial. JAMA Surg. 2014 Jul;149(7):716-26. doi: 10.1001/jamasurg.2014.514.'}, {'pmid': '25909333', 'type': 'RESULT', 'citation': 'Ding SA, Simonson DC, Wewalka M, Halperin F, Foster K, Goebel-Fabbri A, Hamdy O, Clancy K, Lautz D, Vernon A, Goldfine AB. Adjustable Gastric Band Surgery or Medical Management in Patients With Type 2 Diabetes: A Randomized Clinical Trial. J Clin Endocrinol Metab. 2015 Jul;100(7):2546-56. doi: 10.1210/jc.2015-1443. Epub 2015 Apr 24.'}, {'pmid': '26600045', 'type': 'RESULT', 'citation': 'Yu EW, Wewalka M, Ding SA, Simonson DC, Foster K, Holst JJ, Vernon A, Goldfine AB, Halperin F. Effects of Gastric Bypass and Gastric Banding on Bone Remodeling in Obese Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Feb;101(2):714-22. doi: 10.1210/jc.2015-3437. Epub 2015 Nov 24.'}, {'pmid': '27555097', 'type': 'RESULT', 'citation': 'Panosian J, Ding SA, Wewalka M, Simonson DC, Goebel-Fabbri A, Foster K, Halperin F, Vernon A, Goldfine AB. Physical Activity in Obese Type 2 Diabetes After Gastric Bypass or Medical Management. Am J Med. 2017 Jan;130(1):83-92. doi: 10.1016/j.amjmed.2016.07.019. Epub 2016 Aug 20.'}, {'pmid': '29432125', 'type': 'RESULT', 'citation': 'Simonson DC, Halperin F, Foster K, Vernon A, Goldfine AB. Clinical and Patient-Centered Outcomes in Obese Patients With Type 2 Diabetes 3 Years After Randomization to Roux-en-Y Gastric Bypass Surgery Versus Intensive Lifestyle Management: The SLIMM-T2D Study. Diabetes Care. 2018 Apr;41(4):670-679. doi: 10.2337/dc17-0487. Epub 2018 Feb 6.'}, {'pmid': '31931977', 'type': 'RESULT', 'citation': 'Simonson DC, Vernon A, Foster K, Halperin F, Patti ME, Goldfine AB. Adjustable gastric band surgery or medical management in patients with type 2 diabetes and obesity: three-year results of a randomized trial. Surg Obes Relat Dis. 2019 Dec;15(12):2052-2059. doi: 10.1016/j.soard.2019.03.038. Epub 2019 Apr 16.'}, {'pmid': '34845204', 'type': 'DERIVED', 'citation': 'Dreyfuss JM, Yuchi Y, Dong X, Efthymiou V, Pan H, Simonson DC, Vernon A, Halperin F, Aryal P, Konkar A, Sebastian Y, Higgs BW, Grimsby J, Rondinone CM, Kasif S, Kahn BB, Foster K, Seeley R, Goldfine A, Djordjilovic V, Patti ME. High-throughput mediation analysis of human proteome and metabolome identifies mediators of post-bariatric surgical diabetes control. Nat Commun. 2021 Nov 29;12(1):6951. doi: 10.1038/s41467-021-27289-2.'}]}, 'descriptionModule': {'briefSummary': 'There is substantial clinical evidence regarding the safety and efficacy of currently practiced bariatric surgical techniques to improve metabolic control and/or resolve type 2 diabetes (T2DM) in clinically severe obese patients (class 3 obesity). Evidence suggests such procedures have greater effects on insulin secretion and insulin action than that expected from weight loss alone, which has led to the recent claim that such procedures may be useful as a primary treatment for T2DM in the moderately obese population. Concurrently, there have also been substantial advances in the non-surgical medical management of T2DM. As a result, the best treatment algorithm for T2DM patients with class 1 \\& 2 obesity is increasingly controversial. This trial investigates the utility of currently practiced and available bariatric surgical procedures as compared with multidisciplinary intensive medical and weight management for the treatment of T2DM with class 1 and 2 obesity.', 'detailedDescription': "Primary Specific Aim 1: To evaluate the effectiveness of laparoscopic adjustable gastric band versus intensive medical and weight management in the treatment of T2DM.\n\nThere has been only one randomized control trial to date comparing surgical to medical management of T2DM in the less obese population, which demonstrated substantial superiority of the laparoscopic adjustable gastric band (LAGB) in the improvement of glycemic and metabolic measures. However, these findings remain controversial as the magnitude of weight loss in this study was far superior to that generally reported following LAGB. Thus, we propose a second prospective randomized trial to evaluate the effectiveness of intensive medical and weight management (IMWM) vs. LAGB in T2DM patients with BMI in the 30-42 kg/m\\^2 range. This range does extend LAGB surgery to BMI limits below those currently used in medical care, FDA Investigational Device Exemption (IDE) G090163. The primary outcome variable will be attaining glycemic control (as defined by fasting plasma glucose levels \\<126 mg/dL and HbA1c \\<6.5%) at one year of follow-up. The study was subsequently extended to 3 years, with the same outcome measures.\n\nPrimary Specific Aim 2: To evaluate the effectiveness of laparoscopic Roux-en-Y gastric bypass versus intensive medical and weight management in the treatment of T2DM.\n\nAlthough observational studies and meta-analyses suggest rapid and sustained improvement or resolution of diabetes following laparoscopic Roux-en-Y gastric bypass (LRYGB), to date there has been no randomized trial directly comparing these effects to those produced by IMWM. We propose a prospective randomized trial comparing the effectiveness of IMWM vs. LRYGB in T2DM patients with BMI's in the 30-42 kg/m\\^2 range. This range extends LRYGB surgery to BMI limits below those currently used in medical care to explore the use of this type of surgical procedure in type 2 diabetes with lesser magnitude obesity. The primary outcome variable will be attaining glycemic control (as defined by fasting plasma glucose levels \\<126 mg/dL and HbA1c \\<6.5%) at one year of follow-up. The study was subsequently extended to 3 years, with the same outcome measures.\n\nThe trial is designed to allow for strong patient preference towards specific surgical procedures, and as such is designed as two parallel trials with each of the two surgical procedures judged against intensive medical weight management. Subjects without strong preference will be randomly assigned to one of the four study arms.\n\nSecondary Specific Aims:\n\nDetermination of suitable study design: In addition to testing the effectiveness of current and available surgical techniques as compared to medical management, this trial will also test the utility of this trial design in future multi-institutional comparative effectiveness studies of these therapies, or alternatively, in future trials evaluating new surgical procedures being designed specifically for less obese T2DM patients.\n\nMeasurement of metabolic factors: Insulin secretion and action will be assessed during provocative mixed meal tolerance tests (MMTT) using the corrected incremental insulin response (CIR) and the composite insulin sensitivity index (CISI). MMTT will be performed in all groups at baseline and repeated at the time point of 10% weight loss (matched for weight loss), and at 12 months following randomization (matched for time).\n\nMeasurement of cardiovascular risk factors: Each group will be studied for evidence of changes in cardiovascular disease risk factors. Multiple surrogate measures of cardiovascular health will be compared, including blood pressure, fasting lipid profiles, endothelium-dependent vasodilatation and plasma will be collected for circulating markers of endothelial function. The study was subsequently extended to 3 years, with the same outcome measures.\n\nMeasurement of metabolic rate: Each group will be studied for change in energy expenditure and respiratory quotient using the non-invasive indirect calorimetry technique.\n\nQuality of life and cost utility outcomes: Longitudinal measures of patient reported quality of life outcomes, and cost utility measures will also be collected to generate preliminary data for future studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Potential participants will be those with T2DM, with a diagnosis of diabetes of at least one year in duration,\n* BMI 30-45 kg/m\\^2 for the LAGB compared to intensive medical weight and diabetes management and BMI 30-42 kg/m\\^2 for LRYGB compared to intensive medical weight and diabetes management,\n* Age 21-65 years,\n* With a strong desire for substantial weight loss, who are free from active cardiovascular or other diseases that would render them unable to partake in a structured exercise program or to undergo a bariatric surgical procedure, and who are committed to life long medical and nutritional follow up.\n\nExclusion Criteria:\n\n* Detectable levels of glutamic acid decarboxylase (GAD) antibody or a history of diabetic ketoacidosis or uncontrolled T2DM (consistent fasting blood glucose \\>200 mg/dl or HbA1c above twice normal);\n* Previous gastrointestinal surgery, inflammatory bowel disease, esophageal diseases including severe intractable esophagitis, Barrett's Disease, esophageal dysmotility or other impaired gastric motility (gastroparesis), or hiatal hernia \\>3 cm in size, chronic or acute bleeding conditions including peptic ulcer disease, portal hypertension (gastric or esophageal varices), chronic pancreatitis, or cirrhosis of the liver;\n* Malignant or debilitating medical conditions, severe cardiopulmonary disease including uncontrolled hypertension (repeated systolic measures \\>160 or diastolic \\> 95 mm Hg on more than one day), unstable angina pectoris, recent myocardial infarction within 6 months, history of coronary artery bypass surgery or angioplasty, congestive heart failure, arrhythmia, stroke or transient ischemic attacks, urinary albumin excretion \\>300 mcg/mg creatinine and/or serum creatinine \\>1.5 mg/dL (permitting safety of increased dietary protein intake),\n* Any endocrine disorder other than T2DM or thyroid disease which is stable on replacement therapy, including Cushing's syndrome;\n* Any previous history of eating disorders, history of drug and/or alcohol abuse within 2 years of the screening visit, history of impaired mental status as defined by Diagnostic and Statistical Manual, 4th Edition (DSM-4) criteria and including, but not limited to active substance abuse, a history of schizophrenia, borderline personality disorder, uncontrolled depression, suicidal attempts within the past two years or current suicidal tendencies or ideations.\n* Subjects will be excluded if there is a history of significant weight loss (\\>3%) within the previous 3 months or participation in alternate medically supervised exercise or weight reduction program within the previous 3 months, or with use of prescription or over the counter weight reduction medications or supplements within one month of the Screening Visit and for the duration of study participation.\n* Women who are lactating, planning pregnancy, or unwilling to use contraception during the course of the trial."}, 'identificationModule': {'nctId': 'NCT01073020', 'acronym': 'SLIMM-T2D', 'briefTitle': 'Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Joslin Diabetes Center'}, 'officialTitle': 'Surgery or Lifestyle With Intensive Medical Management in the Treatment of Type 2 Diabetes (SLIMM-T2D)', 'orgStudyIdInfo': {'id': '2009P-001610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gastric Band vs Intensive Diabetes & Weight Management', 'description': 'Patients will be randomized to receive either 1) laparoscopic placement of an adjustable gastric band (LAGB) or 2) treatment with an intensive medical and weight management (IMWM) program.\n\nLAGB will be placed using the "pars flaccida" technique. The Allergan laparoscopic band "LAP BAND" system will be utilized. LAGB ports will be placed in subcutaneous pockets in the right upper abdomen.\n\nThe IMWM group will participate in the Weight Achievement and Intensive Treatment (Why WAIT) program, which is a multidisciplinary program for weight control and intensive diabetes management designed by Joslin Diabetes Center. Key aspects include: 1) Intensive and interactive medication adjustments, 2) Structured modified dietary intervention, 3) Graded, balanced, and individualized exercise intervention, 4) Cognitive behavioral intervention and 5) Group education.', 'interventionNames': ['Device: Allergan Adjustable Gastric Band Surgery', 'Other: Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RYGB vs Intensive Diabetes & Weight Management', 'description': 'Patients will be randomized to receive either 1) Roux-en-Y gastric bypass (RYGB) surgery or 2) treatment with an intensive medical and weight management (IMWM) program.\n\nRYGB will be performed using a 75 cm antecolic, ante-gastric Roux limb created with a 50 cm pancreaticobiliary limb. A 15-20 cc gastric pouch will be created lying along the lesser curve of the stomach, with division of the vagal trunks at the lower border of the pouch.\n\nThe IMWM group will participate in the Weight Achievement and Intensive Treatment (Why WAIT) program, which is a multidisciplinary program for weight control and intensive diabetes management designed by Joslin Diabetes Center. Key aspects include: 1) Intensive and interactive medication adjustments, 2) Structured modified dietary intervention, 3) Graded, balanced, and individualized exercise intervention, 4) Cognitive behavioral intervention and 5) Group education.', 'interventionNames': ['Procedure: Roux-en-Y Gastric Bypass (RYGB) Surgery', 'Other: Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group']}], 'interventions': [{'name': 'Allergan Adjustable Gastric Band Surgery', 'type': 'DEVICE', 'armGroupLabels': ['Gastric Band vs Intensive Diabetes & Weight Management']}, {'name': 'Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group', 'type': 'OTHER', 'description': 'Intensive Medical Diabetes \\& Weight Management (Why WAIT) - Band Group', 'armGroupLabels': ['Gastric Band vs Intensive Diabetes & Weight Management']}, {'name': 'Roux-en-Y Gastric Bypass (RYGB) Surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['RYGB vs Intensive Diabetes & Weight Management']}, {'name': 'Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group', 'type': 'OTHER', 'description': 'Intensive Medical Diabetes \\& Weight Management (Why WAIT) - Bypass Group', 'armGroupLabels': ['RYGB vs Intensive Diabetes & Weight Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Allison B. Goldfine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joslin Diabetes Center'}, {'name': 'Ashley Vernon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joslin Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}