Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT00887302
Status:
COMPLETED
Last Update Posted:
2023-10-06
First Post:
2009-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolomics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy
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'}], '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'}, {'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': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Samples will be collected and banked for discovery/analyses of the hypothesized GDPF and/or GDRF in subsequent studies , which are not included in the work plan or budget for this protocol extension. The basis for this proposal is the meta analysis that compares the reversal of diabetes by different bariatric surgery procedures.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2012-10-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2009-04-22', 'studyFirstSubmitQcDate': '2009-04-22', 'lastUpdatePostDateStruct': {'date': '2023-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolics of RYGB with Gastrostomy - Insulin', 'timeFrame': '03/25/2009-10/12/2012', 'description': 'The patient will be weighed after voiding. The weight will then be used to determine the amount of insulin to be administered during the minimal model. The following formulas will be used to calculate the insulin dosages:\n\nREGULAR INSULIN: body mass (kg) X 0.025 U'}, {'measure': 'Metabolics of RYGB with Gastrostomy - Glucose', 'timeFrame': '03/25/2009-10/12/2012', 'description': 'The patient will be weighed after voiding. The weight will then be used to determine the amount of glucose to be administered during the minimal model. The following formulas will be used to calculate the glucose dosages:\n\nGLUCOSE: mls of 50% solution of glucose= body mass (kg) X 0.3g X 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type II Diabetes Mellitus', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This study is an investigation of the "metabolomics of RYGB with gastrostomy."', 'detailedDescription': 'The rapid and durable remission of type II diabetes mellitis following the gastric bypass operation challenges the current concepts about the etiology of the disease. The surgery, which excludes food from the stomach, duodenum, and proximal jejunum, is quickly followed by a durable drop in glucose and insulin levels. As a result, 4 out of 5 diabetic, morbidly obese individuals who undergo the operation return to a long-term euglycemia with a prolongation of life and a reduction of health care costs.\n\nThe investigators at East Carolina University and those at Johnson and Johnson propose to further complete the profile of the upper gut by extending their observation to three additional human models. The investigators will study patients having the gastric band procedure, the gastric sleeve procedure, and those who have a gastric bypass but have a PEG tube inserted later.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Obese caucasian females between the ages of 18-60 who have had bariatric surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* 18-60 years of age\n* BMI of 35-65\n* Willing to comply with study requirements and long term follow-up\n* Capable of understanding the requirements and consequences of surgery and the study\n* Is scheduled to have bariatric surgery performed\n* Has a negative pregnancy test\n\nExclusion Criteria:\n\n* Repeat gastric bypass procedure\n* Patients who are unable to hold their insulin coverage for 48 hours prior to research visits\n* Patients taking TZDs'}, 'identificationModule': {'nctId': 'NCT00887302', 'briefTitle': 'Metabolomics of Roux-en-Y Gastric Bypass (RYGB) With Gastrostomy', 'organization': {'class': 'OTHER', 'fullName': 'East Carolina University'}, 'officialTitle': 'Johnson and Johnson Ethicon Metabolomics of RYGB With Gastrostomy', 'orgStudyIdInfo': {'id': 'J&J Ethicon'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Restricted food intake without rerouting food flow cohort', 'description': 'Obese non-diabetic patients and diabetic patients undergoing gastric band surgery will be studied before they have surgery, 1 week after the band is adjusted to restrict food intake and again after they have lost the weight equal to that which gastric bypass patients loose 3 months after surgery (to match data we already have in the current study). All patients will be studied with an intravenous glucose tolerance test to measure insulin sensitivity and IV glucose-induced insulin secretion and a meal challenge to measure the secretion of metabolites and peptides.', 'interventionNames': ['Procedure: Gastric Band']}, {'label': 'Response to meal when a portion of the stomach is excluded from food flow cohort', 'description': 'Obese-diabetic patient undergoing gastric sleeve surgery will be studied before they have surgery, 1 week after surgery and again 3-6 months after surgery (to match data we already have in the current study). The patient will be studied with an intravenous glucose tolerance test to measure insulin sensitivity and insulin secretion and a meal challenge to measure the secretion of metabolites and peptides.', 'interventionNames': ['Procedure: Gastric Sleeve']}, {'label': 'Response to meal when a portion of the GI tract is excluded from food flow cohort', 'description': 'In approximately 6 patients/year our surgeons have to insert a gastrostomy tube into the bypassed stomach of gastric bypass patients. This provides a unique opportunity to see the changes in metabolites and peptides in blood in response to a meal delivered to the bypassed stomach, duodenum and proximal jejunum. Since we can not anticipate which patients will require this procedure, we cannot do tests before surgery, but we will do four tests post-operatively: (1) an IV glucose tolerance test, (2) an oral meal challenge (with Hi-cal), and (3) a meal challenge (identical to that given orally/Hi-Cal) delivered through the gastrostomy tube.\n\nGastrostomy subjects will also have a 4) test, a 75 gram dextrose meal challenge.', 'interventionNames': ['Procedure: Gastrostomy Tube']}], 'interventions': [{'name': 'Gastric Band', 'type': 'PROCEDURE', 'description': 'Places a band over the upper portion of the stomach.', 'armGroupLabels': ['Restricted food intake without rerouting food flow cohort']}, {'name': 'Gastric Sleeve', 'type': 'PROCEDURE', 'description': 'Stapling stomach vertically to reduce size of stomach and removal of larger curve portion of the stomach', 'armGroupLabels': ['Response to meal when a portion of the stomach is excluded from food flow cohort']}, {'name': 'Gastrostomy Tube', 'type': 'PROCEDURE', 'description': 'Tube is inserted into the stomach that delivers nutrition directly into the stomach.', 'armGroupLabels': ['Response to meal when a portion of the GI tract is excluded from food flow cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University Brody School of Medicine', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}], 'overallOfficials': [{'name': 'Walter Pories, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Carolina University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Carolina University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}