Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-29 @ 7:27 PM
Study NCT ID:
NCT01938469
Status:
COMPLETED
Last Update Posted:
2016-12-29
First Post:
2013-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-28', 'studyFirstSubmitDate': '2013-08-21', 'studyFirstSubmitQcDate': '2013-09-04', 'lastUpdatePostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in gut peptides after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.', 'timeFrame': '1 month before GBP Surgery, and 12-15 months post surgery'}, {'measure': 'Changes in diet induced thermogenesis after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.', 'timeFrame': '1 month before GBP surgery, and 12-15 months post surgery'}, {'measure': 'Changes in insulin levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.', 'timeFrame': '1 month before GBP surgery, 12-15 months post surgery'}, {'measure': 'Changes in glucose levels after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.', 'timeFrame': '1 month before GBP , 12-15 months post GBP'}, {'measure': 'Changes in satiety after gastric bypass, during either a liquid or solid meal, or single or multiple isocaloric meals.', 'timeFrame': '1 month before GBP, 12-15 months post GBP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bariatric', 'Gastric Bypass', 'Gastric Banding,', 'Incretins', 'glucagon-like peptide-1(GLP-1)', 'gastric inhibitory peptide (GIP)'], 'conditions': ['Gastric Bypass Surgery', 'Obesity']}, 'descriptionModule': {'briefSummary': 'Analyze the effect of meal pattern (meal number, frequency, and form) on satiety, gut peptides, insulin, and glucose levels in individuals before and 12-15 months after gastric bypass surgery (GBP).', 'detailedDescription': 'The main goal is to study the effect of meal number, size and texture on metabolism and incretin levels after GBP. Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1, patients will come for 2 study days for 8 hours: On one study day, a single meal will be served, on the second study day, three small isocaloric meals, with the order of the conditions randomly assigned. The total amount of calories and the overall nutrient composition will be equivalent between conditions. The meals will be either all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or liquid test meals.\n\nGastric emptying will be measured by the acetaminophen test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severely obese patients undergoing gastric bypass surgery (GBP)'}, 'identificationModule': {'nctId': 'NCT01938469', 'briefTitle': 'Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's-Roosevelt Hospital Center"}, 'officialTitle': 'Effect of Meal Number, Frequency, and Form on Satiety and Metabolism After Weight Loss Surgery', 'orgStudyIdInfo': {'id': '09-117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Solid Meal', 'description': 'Participants in this group will be administered only solid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).', 'interventionNames': ['Other: Solid Meal']}, {'type': 'OTHER', 'label': 'Liquid Meal', 'description': 'Participants in this group will be administered only liquid meals on both study visits completed before surgery (T0) and 12-15 months after (T1).', 'interventionNames': ['Other: Liquid Meal']}], 'interventions': [{'name': 'Liquid Meal', 'type': 'OTHER', 'armGroupLabels': ['Liquid Meal']}, {'name': 'Solid Meal', 'type': 'OTHER', 'armGroupLabels': ['Solid Meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'St. Lukes- Roosevelt Hospital- New York Obesity Research Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Blandine Laferrere, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Obesity Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's-Roosevelt Hospital Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}