Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-01-01 @ 10:37 AM
Study NCT ID:
NCT00780195
Status:
COMPLETED
Last Update Posted:
2014-12-11
First Post:
2008-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Adaptations to Diabetes in African Americans
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007003', 'term': 'Hypoglycemia'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015309', 'term': 'Glucose Clamp Technique'}], 'ancestors': [{'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-10', 'studyFirstSubmitDate': '2008-10-24', 'studyFirstSubmitQcDate': '2008-10-24', 'lastUpdatePostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'catecholamines', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hypoglycemia', 'African Americans'], 'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': "We do not know why diabetic patients cannot protect themselves against low blood sugar. Therefore, in this study, we will perform a comprehensive assessment of the body's response to low blood sugar by measuring changes in blood hormones, blood sugar production, and nerve signals.", 'detailedDescription': 'Morning and afternoon hypoglycemic episodes of 70, 60, or 50 mg/dl produce increased blunting of subsequent counterregulation dependent upon the depth of preceding hypoglycemia. We wanted to test this hypothesis in healthy African American individuals to determine if there is a difference in their responses to varying depths of hypoglycemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and females aged 18-40 yrs with no family history of diabetes mellitus.\n* All prospective volunteers will have routine blood tests to screen for biochemical, hormonal and hematological abnormalities.\n* Female volunteers will also undergo an HCG urine pregnancy test.\n\nExclusion Criteria:\n\n* Prior or current history of poor health\n* Abnormal results following blood and physical examination\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00780195', 'briefTitle': 'Metabolic Adaptations to Diabetes in African Americans', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Metabolic Adaptations to Diabetes', 'orgStudyIdInfo': {'id': 'IRB # 8177'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Single 2 hour hyperinsulinemic euglycemic clamp study at \\~90 mg/dl.', 'interventionNames': ['Procedure: glucose clamp']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Single 2 hour hyperinsulinemic hypoglycemic clamp study at \\~70 mg/dl.', 'interventionNames': ['Procedure: glucose clamp']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Single 2 hour hyperinsulinemic hypoglycemic clamp at \\~60 mg/dl.', 'interventionNames': ['Procedure: glucose clamp']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': 'Single, 2 hour hyperinsulinemic hypoglycemic clamp at \\~50 mg/dl.', 'interventionNames': ['Procedure: glucose clamp']}], 'interventions': [{'name': 'glucose clamp', 'type': 'PROCEDURE', 'description': '2 hour hyperinsulinemic euglycemic clamp (90 mg/dl)', 'armGroupLabels': ['1']}, {'name': 'glucose clamp', 'type': 'PROCEDURE', 'description': '2 hour hyperinsulinemic hypoglycemic clamp (70 mg/dl)', 'armGroupLabels': ['2']}, {'name': 'glucose clamp', 'type': 'PROCEDURE', 'description': '2 hour hyperinsulinemic hypoglycemic clamp (60 mg/dl)', 'armGroupLabels': ['3']}, {'name': 'glucose clamp', 'type': 'PROCEDURE', 'description': '2 hour hyperinsulinemic hypoglycemic clamp (50 mg/dl)', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stephen N. Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department Chair', 'investigatorFullName': 'Steve Davis', 'investigatorAffiliation': 'Vanderbilt University'}}}}