Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-31 @ 5:46 PM
Study NCT ID:
NCT01218633
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2010-10-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-response Study of Exendin-9,39 on Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-18', 'studyFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Secretion', 'timeFrame': 'over 360 minutes of study'}], 'secondaryOutcomes': [{'measure': 'glucagon secretion', 'timeFrame': 'over 360 minutes of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pancreatic Effects of 9,39-Exendin and 9,36-GLP-1']}, 'referencesModule': {'references': [{'pmid': '23545708', 'type': 'DERIVED', 'citation': 'Sathananthan M, Farrugia LP, Miles JM, Piccinini F, Dalla Man C, Zinsmeister AR, Cobelli C, Rizza RA, Vella A. Direct effects of exendin-(9,39) and GLP-1-(9,36)amide on insulin action, beta-cell function, and glucose metabolism in nondiabetic subjects. Diabetes. 2013 Aug;62(8):2752-6. doi: 10.2337/db13-0140. Epub 2013 Apr 1.'}]}, 'descriptionModule': {'briefSummary': 'Multiple studies have examined the effect of endogenous GLP-1 secretions by using a competitive antagonist of GLP-1 - Exendin-9,39 - infused at rates of 300pmol/kg/min. However, the presence of an effect does not necessarily imply that this effect is due to the blockade of the endogenous GLP-1 actions at the receptor. It is possible that the supraphysiologic concentrations of Exendin may have effects of its own. To examine the effect of Exendin on glucose metabolism the investigators propose a dose-response study to determine whether the compound has effects in a dose-dependent fashion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy Not on any medication other than thyroid hormone replacement or OCP No history of diabetes No prior upper GI surgery'}, 'identificationModule': {'nctId': 'NCT01218633', 'briefTitle': 'Dose-response Study of Exendin-9,39 on Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Dose-response Study of the Effects of Exendin-9,39 on Glucose Metabolism, Glucagon and Insulin Secretion and on Insulin Action.', 'orgStudyIdInfo': {'id': '10-003435'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'interventionNames': ['Drug: saline infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GLP-1-(9,36)-amide', 'interventionNames': ['Drug: GLP-1-9,36 infusion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exendin-9,39 @30pmol/kg/min', 'interventionNames': ['Drug: Exendin-9,39 at low dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exendin-9,39 @300pmol/kg/min', 'interventionNames': ['Drug: Exendin-9,39 at high dose']}], 'interventions': [{'name': 'saline infusion', 'type': 'DRUG', 'description': 'saline infused at 30ml/hour', 'armGroupLabels': ['Saline']}, {'name': 'GLP-1-9,36 infusion', 'type': 'DRUG', 'description': 'infused @ 1.2pmol/kg/min', 'armGroupLabels': ['GLP-1-(9,36)-amide']}, {'name': 'Exendin-9,39 at low dose', 'type': 'DRUG', 'description': 'infused at 30pmol/kg/min', 'armGroupLabels': ['Exendin-9,39 @30pmol/kg/min']}, {'name': 'Exendin-9,39 at high dose', 'type': 'DRUG', 'description': 'infused @ 300pmol/kg/min', 'armGroupLabels': ['Exendin-9,39 @300pmol/kg/min']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Adrian Vella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adrian Vella', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Adrian Vella', 'investigatorAffiliation': 'Mayo Clinic'}}}}