Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 12:01 AM
Study NCT ID:
NCT00996294
Status:
UNKNOWN
Last Update Posted:
2010-01-12
First Post:
2009-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015904', 'term': 'Biliopancreatic Diversion'}, {'id': 'D015390', 'term': 'Gastric Bypass'}], 'ancestors': [{'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-11', 'studyFirstSubmitDate': '2009-10-15', 'studyFirstSubmitQcDate': '2009-10-15', 'lastUpdatePostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes control, define by FSG and HbA1c', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Diabetes control defined by FSG and HbA1c', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Bariatric Surgery', 'Biliopancreatic Diversion', 'Gastric Bypass']}, 'referencesModule': {'references': [{'pmid': '24647849', 'type': 'DERIVED', 'citation': 'Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, Andraghetti G, Catalano M, Cordera R. Effects of gastric bypass on type 2 diabetes in patients with BMI 30 to 35. Obes Surg. 2014 Jul;24(7):1036-43. doi: 10.1007/s11695-014-1206-1.'}, {'pmid': '21541815', 'type': 'DERIVED', 'citation': "Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Briatore L, D'Alessandro G, Parodi C, Weiss A, Andraghetti G, Catalano M, Cordera R. The effects of biliopancreatic diversion on type 2 diabetes mellitus in patients with mild obesity (BMI 30-35 kg/m2) and simple overweight (BMI 25-30 kg/m2): a prospective controlled study. Obes Surg. 2011 Jul;21(7):880-8. doi: 10.1007/s11695-011-0407-0."}, {'pmid': '21475009', 'type': 'DERIVED', 'citation': "Scopinaro N, Adami GF, Papadia FS, Camerini G, Carlini F, Fried M, Briatore L, D'Alessandro G, Andraghetti G, Cordera R. Effects of biliopanceratic diversion on type 2 diabetes in patients with BMI 25 to 35. Ann Surg. 2011 Apr;253(4):699-703. doi: 10.1097/SLA.0b013e318203ae44."}]}, 'descriptionModule': {'briefSummary': 'Thirty type 2 diabetic patients will be submitted to biliopancreatic diversion and 20 to gastric bypass. Subjects will be monitored during a 5 year period to assess the effects of the operations on diabetes control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Type 2 diabetes mellitus\n* Duration of diabetes ≥ 3 years\n* Poor glycemic control (i.e., HbA1c ≥ 7.5%) in spite of hypoglycemic therapy in accordance with good clinical practice (GCP)\n\nExclusion Criteria:\n\n* Specific contraindication to obesity surgery or biliopancreatic diversion or gastric bypass\n* Pregnancy\n* Medical conditions requiring acute hospitalisation\n* Severe diabetes complications or associated medical conditions \\[such as blindness, end-stage renal failure (i.e. serum creatinine \\>2 mg/dl), liver cirrhosis, malignancy, chronic congestive heart failure (NYHA class III and IV)\\]\n* Recent (within preceding 12 months) myocardial infarction, stroke or TIA\n* Unstable angina pectoris\n* Psychological conditions which may hamper patient's cooperation\n* Geographic inaccessibility\n* Any condition which, in the judgment of the Investigator, may make risky the participation in the study or bias the results"}, 'identificationModule': {'nctId': 'NCT00996294', 'briefTitle': 'Surgical Treatment of Type 2 Diabetes Mellitus in <35 Body Mass Index (BMI)', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy'}, 'officialTitle': 'Surgical Treatment of Type 2 Diabetes Mellitus in Patients With BMI <35 kg/m2 (Italian Title: "La Terapia Chirurgica Del Diabete Mellito di Tipo 2 Nel Paziente Con BMI Inferiore a 35 kg/m2")', 'orgStudyIdInfo': {'id': 'DIA-CHIR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surgery', 'description': 'patients will be submitted to biliopancreatic diversion or gastric bypass', 'interventionNames': ['Procedure: biliopancreatic diversion, gastric bypass']}], 'interventions': [{'name': 'biliopancreatic diversion, gastric bypass', 'type': 'PROCEDURE', 'description': 'biliopancreatic diversion consists of a distal gastrectomy with a long Roux-en-Y reconstruction, where the enteroenterostomy is placed 50 cm proximal to the ileocecal valve gastric bypass consists of creating a small proximal gastric pouch by division of the upper stomach, with reconstruction of the GI continuity by means of a Roux-en-Y loop', 'armGroupLabels': ['surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'Ospedale San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}], 'overallOfficials': [{'name': 'Nicola Scopinaro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda Ospedaliera Universitaria "San Martino", Genova, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Nicola Scopinaro', 'oldOrganization': 'Azienda Ospedaliera Universitaria "San Martino", Genova, Italy'}}}}