Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT01046994
Status:
UNKNOWN
Last Update Posted:
2010-01-12
First Post:
2010-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion
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': 'D007004', 'term': 'Hypoglycemic Agents'}], 'ancestors': [{'id': 'D001662', 'term': 'Biliary Tract Surgical Procedures'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-01-11', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diabetes control as defined by FSG and HbA1c', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Diabetes control as defined by FSG and HbA1c', 'timeFrame': '5 years'}, {'measure': 'Assessment of prevalence and severity of diabetes complications', 'timeFrame': '5 years'}, {'measure': 'Assessment of patient BMI', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'Bariatric Surgery', 'Biliopancreatic Diversion']}, 'descriptionModule': {'briefSummary': 'A previous prospective study of BPD effect on type 2 diabetes patients with BMI 25-35 (DIA-CHIR) showed that T2DM is less sensitive to BPD beneficial effect in the simply overweight patients. A new prospective study was then planned with the aim to gain insight in the mechanism of action of BPD in T2DM patients in the 25-30 BMI range. Thirty patients will be submitted to BPD and compared with 10 nonoperated controls. Euglycemic-hyperinsulinemic clamp, OGTT, and mixed meal test will be performed in all subjects preoperatively, and 1 month, 1 year, and 5 years after BPD. Complete clinical and biochemical evaluations will be performed at 1, 4, 8, and 12 months, and every sixth month thereafter until the end of the fifth year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age: 35-70 years\n* diabetes duration: \\>5 years\n* documented poor glycemic control (HbA1c =\\>8% despite medical treatment according to GCP)\n* presence of comorbidities or complications (e.g. dyslipidemia, arterial hypertension, neuropathy, retinopathy, CVD, previous stroke or TIA, lower limb amputation)\n* availability to comply with the entire follow-up\n\nExclusion Criteria:\n\n* general contraindications to BPD (applies also to medical controls)\n* presence of anti-islet or anti-GAD antibodies or plasma C-peptide concentration \\<0.5 mcg/L\n* blindness\n* severe concomitant medical conditions (e.g. liver cirrhosis, renal failure, collagen diseases, severe endocrinopathies)\n* heart failure\n* recent history (less than 12 months) of myocardial infarction, stroke or TIA\n* unstable angina\n* pregnancy\n* previous or concomitant malignancy\n* severe active inflammatory, neurologic, or cardiovascular conditions\n* geographic inaccessibility\n* any condition which, in the opinion of the Principal Investigator, may make risky the participation in the study or bias the results'}, 'identificationModule': {'nctId': 'NCT01046994', 'acronym': 'DIA-BPD 25-30', 'briefTitle': 'Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy'}, 'officialTitle': 'Prospective Controlled Trial on Surgical Treatment of Type 2 Diabetes Patients With BMI 25-30 by Means of Biliopancreatic Diversion', 'orgStudyIdInfo': {'id': 'DIA-BPD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surgery', 'description': 'biliopancreatic diversion', 'interventionNames': ['Procedure: biliopancreatic diversion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard medical care', 'description': 'patients treated according to the rules of good clinical practice', 'interventionNames': ['Drug: antidiabetics']}], 'interventions': [{'name': 'biliopancreatic diversion', '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', 'armGroupLabels': ['surgery']}, {'name': 'antidiabetics', 'type': 'DRUG', 'description': 'patients are treated with conventional antidiabetic drugs according to the rules of good clinical practice', 'armGroupLabels': ['standard medical care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Scopinaro, MD', 'role': 'CONTACT', 'email': 'nicola.scopinaro@unige.it', 'phone': '+39 010 3537301'}, {'name': 'Nicola Scopinaro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}], 'centralContacts': [{'name': 'Nicola Scopinaro, MD', 'role': 'CONTACT', 'email': 'nicola.scopinaro@unige.it', 'phone': '+39 010 3537301'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Santa Chiara Hospital', 'class': 'OTHER'}, {'name': 'Istituto Nazionale per lo Studio e la Cura dei Tumori', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Nicola Scopinaro, Professor of Surgery', 'oldOrganization': 'Azienda Ospedaliera Universitaria San Martino'}}}}