Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-03 @ 10:54 PM
Study NCT ID:
NCT00957957
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2009-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-19', 'studyFirstSubmitDate': '2009-08-11', 'studyFirstSubmitQcDate': '2009-08-12', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP', 'timeFrame': 'Baseline and Week 4'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in PYY measured by dMS 4 weeks after RYGBP', 'timeFrame': 'Baseline and week 4'}]}, 'conditionsModule': {'conditions': ['Obesity, Morbid', 'Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '28265415', 'type': 'DERIVED', 'citation': 'Shankar SS, Mixson LA, Chakravarthy M, Chisholm R, Acton AJ, Jones R, Mattar SG, Miller DL, Petry L, Beals CR, Stoch SA, Kelley DE, Considine RV. Metabolic improvements following Roux-en-Y surgery assessed by solid meal test in subjects with short duration type 2 diabetes. BMC Obes. 2017 Mar 1;4:10. doi: 10.1186/s40608-017-0149-1. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Morbidly obese type 2 diabetic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented type 2 diabetes with total disease duration ≤10 years\n* BMI of at least 35 kg/m\\^2\n* Patient is a surgical candidate for either RYGBP, GBS or vertical sleeve gastrectomy (VSG)\n\nExclusion Criteria:\n\n* Any illness that might confound the results of the study or pose additional risk to the patient by participation\n* History of stroke, seizures, or other major neurological disorder\n* History of cancer\n* Patient uses or has used any medication that can alter body weight\n* Patient is unwilling or unable to follow study procedures'}, 'identificationModule': {'nctId': 'NCT00957957', 'briefTitle': 'Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '0000-134'}, 'secondaryIdInfos': [{'id': '2009_002', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Participants having elective Roux-en-Y gastric bypass surgery (RYGBP)'}, {'label': '2', 'description': 'Participants having elective gastric banding surgery (GB)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}