Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT00200018
Status:
COMPLETED
Last Update Posted:
2009-02-05
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes
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'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-03', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2009-02-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean excess weight loss and percent excess weight loss', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Diabetes status and use of diabetes medication', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity', 'Morbid obesity', 'Diabetes'], 'conditions': ['Severe to Morbid Obesity and Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the effect of an implanted device that stimulates the stomach on weight loss in patients suffering from obesity and type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes with HbA1c of 7.5 - 11%\n* Willing to make behavior and lifestyle modifications\n* No previous bariatric surgery (gastric bypass, gastric banding)\n* Meet additional study criteria\n\nExclusion Criteria:\n\n* History of substance abuse or chemical dependency with in the last 3 years\n* Prior GI surgery for morbid obesity or any gastric surgery for conditions other than obesity or diabetes\n* Severe congestive heart failure\n* Any underlying illness other than diabetes or obesity that affects gastrointestinal motility\n* Currently taking medications for weight loss'}, 'identificationModule': {'nctId': 'NCT00200018', 'acronym': 'ASSIST', 'briefTitle': 'Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedtronicNeuro'}, 'officialTitle': 'ASSIST: Appetite Suppression Induced by Stimulation Trial', 'orgStudyIdInfo': {'id': '1163-85585'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Enterra Therapy System (H9900014)', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Eagan', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.80413, 'lon': -93.16689}}], 'overallOfficials': [{'name': 'ASSIST Team', 'role': 'STUDY_CHAIR', 'affiliation': 'Medtronic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedtronicNeuro', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Kristin Schwartz', 'oldOrganization': 'Medtronic Neuromodulation'}}}}