Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-25 @ 8:49 PM
Study NCT ID:
NCT02518932
Status:
UNKNOWN
Last Update Posted:
2015-08-10
First Post:
2015-06-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-07', 'studyFirstSubmitDate': '2015-06-25', 'studyFirstSubmitQcDate': '2015-08-07', 'lastUpdatePostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of VTC-G15 on whole body glucose metabolism in man will be assessed by comparison of amont of glucose infusion during the peptide infusion compared to amount of infusion during placebo infusion (saline) mg/kg/min.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'THe effect of VTC-G15(A pentapeptide cleavage product of GLP-1) on whole body glucose metabolism in man.', 'timeFrame': 'one year', 'description': 'changes in insulin or glucagon release.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.', 'detailedDescription': "The investigators have previously demonstrated that infusion of the pentapeptide during hyperglycemic clamps in dogs significantly increases the glucose infusion rate necessary to maintain stable hyperglycemia without any significant differences in insulin or glucagon secretion. The present study's aim is to examine whether this also occurs in humans. It may be necessary to examine a dose response curve. Specifically, in twenty healthy volunteers glucose infusion rate during the peptide infusion will be compared to the glucose infusion rate during saline administration during a 4 hour hyperglycemic clamp, in a cross over design(mg/kg/min)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18.5-25;\n* 33-38\n\nExclusion Criteria:\n\n* T2D\n* T1D\n* Hypoglycemic agents'}, 'identificationModule': {'nctId': 'NCT02518932', 'acronym': 'LVKGR', 'briefTitle': 'The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man', 'organization': {'class': 'INDIV', 'fullName': 'Elahi, Dariush, PhD'}, 'officialTitle': 'The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man', 'orgStudyIdInfo': {'id': 'VTC-G15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Drug GLP-1 (32-36) Amide', 'description': 'To examine insulinomemtic of the last 5 amino acids of GLP-1 from 60-180 min during a 4 hour hyperglycemic clamp', 'interventionNames': ['Drug: Last 5 amino acids of GLP-1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'To examine the effect of saline on glucose uptake', 'interventionNames': ['Drug: placebo saline']}], 'interventions': [{'name': 'Last 5 amino acids of GLP-1', 'type': 'DRUG', 'otherNames': ['VTC-G15; LVKGR'], 'description': 'To examine insulinomimetic properties of LVKGR', 'armGroupLabels': ['Drug GLP-1 (32-36) Amide']}, {'name': 'placebo saline', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rita Flusche', 'role': 'CONTACT', 'email': 'Rita.flusche@iconplc.com', 'phone': '210-283-4123'}], 'facility': 'ICON PLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Dariush E;ahi, PhD', 'role': 'CONTACT', 'email': 'dariush.elahi@iconplc.com', 'phone': '210-283-4520'}, {'name': 'Dennis A Ruff, MD', 'role': 'CONTACT', 'email': 'dennis.ruff@iconplc.com', 'phone': '210-283-4572'}], 'overallOfficials': [{'name': 'Dariush Elahi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICON plc, 8307 Gault Lane, San Antonio TX 78209'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elahi, Dariush, PhD', 'class': 'INDIV'}, 'collaborators': [{'name': 'ICON plc', 'class': 'INDUSTRY'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}