Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-02-02 @ 9:15 AM
Study NCT ID:
NCT02023918
Status:
COMPLETED
Last Update Posted:
2017-04-24
First Post:
2013-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'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': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C406545', 'term': 'pegvisomant'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ethan.weiss@ucsf.edu', 'phone': '4155140819', 'title': 'Dr. Ethan Weiss', 'organization': 'UCSF'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pegvisomant Arm', 'description': 'pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegvisomant Arm', 'description': 'Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.'}], 'classes': [{'title': 'Baseline HOMA-IR', 'categories': [{'measurements': [{'value': '3.06', 'spread': '1.46', 'groupId': 'OG000'}]}]}, {'title': 'HOMA-IR after 28 days of treatment', 'categories': [{'measurements': [{'value': '3.33', 'spread': '2.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR.\n\nHOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were compared after treatment to their own baseline'}, {'type': 'SECONDARY', 'title': 'Lipolysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegvisomant Arm', 'description': 'Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.'}], 'classes': [{'title': 'Ra glycerol fasting state baseline', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.07', 'groupId': 'OG000'}]}]}, {'title': 'Ra glycerol fasting state after 28 days of peg', 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.02', 'groupId': 'OG000'}]}]}, {'title': 'Ra glycerol steady state baseline', 'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Ra glycerol steady state treatment 28 days peg', 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Treatment with pegvisomant is expected to alter lipolysis. To assess this investigators will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant.', 'unitOfMeasure': 'mg/kg/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Ra glycerol reported'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegvisomant Arm', 'description': 'Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.\n\npegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegvisomant Arm', 'description': 'pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.5', 'spread': '3.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-20', 'studyFirstSubmitDate': '2013-12-24', 'resultsFirstSubmitDate': '2016-11-09', 'studyFirstSubmitQcDate': '2013-12-24', 'lastUpdatePostDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-23', 'studyFirstPostDateStruct': {'date': '2013-12-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity', 'timeFrame': '28 days', 'description': 'Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR.\n\nHOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5'}], 'secondaryOutcomes': [{'measure': 'Lipolysis', 'timeFrame': '28 days', 'description': 'Treatment with pegvisomant is expected to alter lipolysis. To assess this investigators will do fasting and steady state stable isotope measurements prior to treatment with pegvisomant and at day 28 after treatment with pegvisomant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Growth hormone antagonism'], 'conditions': ['Diabetes', 'Metabolic Syndrome', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Growth hormone is well known to cause changes in glucose regulation. People with Laron syndrome are born without the growth hormone receptor and are protected from diabetes. Mice who are engineered without the growth hormone receptor are similarly protected from diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. In this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 18-35\n* Homeostatic model assessment - insulin resistance (HOMA-IR) \\>2.77\n* Able to administer daily subcutaneous injections of pegvisomant\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding in the last 6 months\n* Liver function tests greater than 3x the upper limits of normal\n* unstable diet over the last 3 months\n* unstable weight over the last 6 months\n* unstable lipid lowering regimen\n* diabetes - type 1 or type 2\n* History of major gastrointestinal surgery\n* History of pancreatic, liver, biliary, or intestinal disease\n* Fasting blood glucose \\>126\n* Fasting triglycerides\\>500\n* A1c\\>6.5'}, 'identificationModule': {'nctId': 'NCT02023918', 'acronym': 'PEGIR', 'briefTitle': 'Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Pre-diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Insulin Resistance But Without Diabetes', 'orgStudyIdInfo': {'id': 'WI178028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pegvisomant arm', 'description': 'Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.', 'interventionNames': ['Drug: pegvisomant']}], 'interventions': [{'name': 'pegvisomant', 'type': 'DRUG', 'otherNames': ['Somavert'], 'description': 'Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.', 'armGroupLabels': ['Pegvisomant arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Ethan J Weiss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Morris Schambelan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Kathleen Mulligan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Francisco General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}