Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-28 @ 2:14 AM
Study NCT ID:
NCT03998293
Status:
WITHDRAWN
Last Update Posted:
2022-12-15
First Post:
2019-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Measurement of Proinsulin Clearance in Humans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013004', 'term': 'Somatostatin'}], 'ancestors': [{'id': 'D010905', 'term': 'Pituitary Hormone Release Inhibiting Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Newly available data suggests that measuring proinsulin clearance would not enhance predictive value of serum proinsulin', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2019-06-24', 'studyFirstSubmitQcDate': '2019-06-25', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proinsulin Clearance', 'timeFrame': 'through study completion, each study will take an average of 8 hours', 'description': 'The half-life of proinsulin in a given individual'}, {'measure': 'Proinsulin Distribution', 'timeFrame': 'through study completion, each study will take an average of 8 hours', 'description': 'The volume of distribution of proinsulin in a given individual'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to determine how quickly proinsulin is cleared from the circulation.', 'detailedDescription': 'proinsulin clearance is necessary to determine the rate of secretion into the circulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Weight-stable, non-diabetic subjects from Biobank participants at Mayo Clinic, Rochester\n\nExclusion Criteria:\n\n* Age \\< 25 or \\> 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).\n* HbA1c ≥ 6.5%\n* Use of glucose-lowering agents.\n* For female subjects: positive pregnancy test at the time of enrollment or study\n* History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.\n* Active systemic illness or malignancy.\n* Symptomatic macrovascular or microvascular disease.\n* Hormone replacement therapy \\>0.625 mg premarin daily'}, 'identificationModule': {'nctId': 'NCT03998293', 'briefTitle': 'Direct Measurement of Proinsulin Clearance in Humans', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Direct Measurement of Proinsulin Clearance in Humans', 'orgStudyIdInfo': {'id': '19-003525'}, 'secondaryIdInfos': [{'id': 'R01DK078645', 'link': 'https://reporter.nih.gov/quickSearch/R01DK078645', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'proinsulin clearance', 'description': 'all participants will be studied once where somatostatin will be used to block endogenous insulin secretion', 'interventionNames': ['Drug: Somatostatin']}], 'interventions': [{'name': 'Somatostatin', 'type': 'DRUG', 'description': 'infused to block endogenous insulin secretion over a 4 hour period', 'armGroupLabels': ['proinsulin clearance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Adrian Vella', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Adrian Vella', 'investigatorAffiliation': 'Mayo Clinic'}}}}