Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT01463904
Status:
UNKNOWN
Last Update Posted:
2011-11-02
First Post:
2011-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'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': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples of subcutaneous and visceral fat, and samples of liver tissue.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-11-01', 'studyFirstSubmitDate': '2011-10-31', 'studyFirstSubmitQcDate': '2011-11-01', 'lastUpdatePostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Morbid obesity', 'duodenal switch', 'diabetes', 'decrease in cardiac risk', 'remission of T2DM'], 'conditions': ['Morbid Obesity', 'Diabetes']}, 'descriptionModule': {'briefSummary': 'Single-Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy is a modified and simplified duodenal switch. It is performed on morbid obese patients and severe T2DM patients with obesity, and a proper weight loss is expected as well as a decrease in the cardiac risk and a remission of T2DM. A lower complication rate than for duodenal switch is expected.', 'detailedDescription': 'A sleeve gastrectomy over a wide bougie is performed. Then the proximal duodenum is divided and anastomosed to the ileum 250 cm from the cecum.\n\nThe preoperative studies and postoperative follow up is similar to those performed before and after other bariatric procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Morbid obesity patients and patients with obesity and T2DM', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 30 with T2DM or BMI \\> 40\n\nExclusion Criteria:\n\n* Oncologic patients, alcoholic patients, mentally retarded'}, 'identificationModule': {'nctId': 'NCT01463904', 'acronym': 'SADI-S 250', 'briefTitle': 'Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications', 'organization': {'class': 'OTHER', 'fullName': 'Hospital San Carlos, Madrid'}, 'officialTitle': 'Single-Anastomosis Duodeno-Ileal Bypass With Sleeve Gastrectomy (SADI-S) for the Treatment of Morbid Obesity and Its Metabolic Complications', 'orgStudyIdInfo': {'id': 'FMMA-08 Sánchez-Pernaute'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Morbid obese, diabetics', 'description': 'Patients with morbid obesity or severe metabolic disease', 'interventionNames': ['Procedure: SADI-S 250']}], 'interventions': [{'name': 'SADI-S 250', 'type': 'PROCEDURE', 'description': 'Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy', 'armGroupLabels': ['Morbid obese, diabetics']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Andrés Sánchez-Pernaute, MD PhD', 'role': 'CONTACT', 'email': 'asanchezp.hcsc@salud.madrid.org', 'phone': '+3413303184'}, {'name': 'Andrés Sánchez-Pernaute, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital San Carlos, Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Andres Sanchez-Pernaute', 'investigatorAffiliation': 'Hospital San Carlos, Madrid'}}}}