Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT01803451
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2013-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007003', 'term': 'Hypoglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C083773', 'term': 'exendin (9-39)'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2013-02-20', 'studyFirstSubmitQcDate': '2013-03-01', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The investigator measure glucose, islet and GI hormonal levels in response to meal ingestion as a composite measure and the percentage of contribution of GLP-1 contribution to postprandial insulin levels will also be calculated', 'timeFrame': 'up to 1 year (10 sessions)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['gastric bypass', 'glucose metabolism', 'hypoglycemia'], 'conditions': ['Post-bariatric Surgery']}, 'referencesModule': {'references': [{'pmid': '24315990', 'type': 'DERIVED', 'citation': "Salehi M, Gastaldelli A, D'Alessio DA. Blockade of glucagon-like peptide 1 receptor corrects postprandial hypoglycemia after gastric bypass. Gastroenterology. 2014 Mar;146(3):669-680.e2. doi: 10.1053/j.gastro.2013.11.044. Epub 2013 Dec 4."}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.\n\nThe central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.\n\n1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.\n2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.\n3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.', 'detailedDescription': 'The overall goal of this project is to understand the mechanisms by which gastric bypass surgery improves glucose metabolism.\n\nThe central hypothesis guiding this project is that the reconfiguration of intestinal transit with the Roux-en-Y will increase the release of insulinotropic GI hormones, termed incretins that improve insulin secretion and glucose metabolism. The study is divided into three specific aims.\n\n1. To determine the role of incretin hormones on insulin secretion in patients with gastric bypass surgery using intravenous-oral hyperglycemic clamp.\n2. To compare incretin effect and glucose tolerance among patient who suffer from hypoglycemia after RYGB and asymptomatic surgical and non-surgical individuals.\n3. To quantify the contribution of GLP-1 to incretin effect enhancement following surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-65\n* healthy control without diabetes or active organ disease\n* Individuals with bariatric surgery\n* recurrent hypoglycemia post gastric bypass\n\nExclusion Criteria:\n\n* pregnancy\n* significant anemia\n* diabetes currently unless pre-op for bariatric surgery procedure\n* GI obstruction'}, 'identificationModule': {'nctId': 'NCT01803451', 'acronym': 'GLP-1', 'briefTitle': 'Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': 'The Role of Glucagon Like Peptide-1 in Glucose Metabolism and Weight Loss Following Gastric Bypass Surgery', 'orgStudyIdInfo': {'id': 'HSC20180070H'}, 'secondaryIdInfos': [{'id': 'DK083554', 'type': 'OTHER', 'domain': 'NIDDK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hyperglycemic clamp-Meal tolerance test', 'description': 'these studies are to evaluate the effect of exendin-9 on insulin secretion before and after meal ingestion in patients after bariatric surgeries compared to non-surgical controls', 'interventionNames': ['Drug: exendin-(9-39)']}, {'type': 'EXPERIMENTAL', 'label': 'Labeled meal tolerance test', 'description': 'The effect of GLP-1 receptor blockade on glucose tolerance and glucose kinetics are evaluated in the group patients with bariatric surgery vs. nonsurgical using exendin-9-39 infusion during one of the the 2-day dual tracer studies of meal tolerance test', 'interventionNames': ['Drug: exendin -(9-39)']}], 'interventions': [{'name': 'exendin-(9-39)', 'type': 'DRUG', 'otherNames': ['no other name for exendin-(9-39)'], 'description': 'hyperglycemic clamp-meal tolerance test is designed to assess insulin secretion before and after meal ingestion', 'armGroupLabels': ['hyperglycemic clamp-Meal tolerance test']}, {'name': 'exendin -(9-39)', 'type': 'DRUG', 'otherNames': ['no other name for exendin-(9-39)'], 'description': '2-day meal tolerance tests with labeled oral and IV glucose using exendin-(9-39) infusion are designed to evaluate the role of GLP-1 signaling on glucose tolerance and glucose kinetics.', 'armGroupLabels': ['Labeled meal tolerance test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Foster, MSN', 'role': 'CONTACT', 'email': 'fosterj6@uthscsa.edu', 'phone': '210-450-8696'}, {'name': 'Marzieh Salehi, MD, MS', 'role': 'CONTACT', 'email': 'salehi@uthscsa.edu', 'phone': '210-567-6691'}], 'facility': 'Texas Diabetes Institute - University Health System', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marzieh Salehi, MD MS', 'role': 'CONTACT', 'email': 'salehi@uthscsa.edu', 'phone': '210-567-6691'}, {'name': 'Jennifer Foster', 'role': 'CONTACT', 'email': 'fosterj6@uthscsa.edu', 'phone': '210-450-8696'}, {'name': 'Marzieh Salehi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'South Texas Veterans Health Care System', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Marzieh Salehi, MD MS', 'role': 'CONTACT', 'email': 'salehi@uthscsa.edu', 'phone': '210-567-6691'}, {'name': 'Jennifer Foster, MSN', 'role': 'CONTACT', 'email': 'fosterj6@uthscsa.edu', 'phone': '210-450-8696'}], 'overallOfficials': [{'name': 'Marzieh Salehi, MD,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marzieh Salehi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}