Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-02 @ 10:48 AM
Study NCT ID:
NCT00592332
Status:
COMPLETED
Last Update Posted:
2014-12-11
First Post:
2008-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000525', 'term': 'Alprazolam'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-10', 'studyFirstSubmitDate': '2008-01-01', 'studyFirstSubmitQcDate': '2008-01-01', 'lastUpdatePostDateStruct': {'date': '2014-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Catecholamine levels', 'timeFrame': 'Comparative study performed every 6-8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': "Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.", 'detailedDescription': 'Due to the fundamental importance of glucose as a cerebral fuel, a complex and redundant counterregulatory response to hypoglycemia exists in man. Some studies have shown that prior activation of GABA(A) receptors may result in blunting of counterregulatory responses during next day hypoglycemia.\n\nThe Specific Aim is to determine if repeated activation of GABA(A) receptors using Alprazolam will result in blunting of neuroendocrine, ANS and metabolic counterregulatory mechanisms during next day hypoglycemia in T1DM and healthy man.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 16 (8 males, 8 females) Type 1 diabetes patients aged 18-45 yr.\n* 16 (8 males, 8 females) healthy controls aged 18-45 yr.\n* HbA1c \\> 7.0% (Type 1 diabetes patients)\n* Had diabetes for 2-15 years (Type 1 diabetes patients)\n* No clinical evidence of diabetic tissue complications (Type 1 diabetes patients)\n* Body mass index 21-30 kg ยท m-2\n* Normal bedside autonomic function\n* Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities\n* Female volunteers of childbearing potential: negative HCG pregnancy test\n\nExclusion Criteria:\n\n* Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease\n* Hemoglobin of less than 12 g/dl\n* Abnormal results following screening tests\n* Pregnancy\n* Subjects unable to give voluntary informed consent\n* Subjects with known liver or kidney disease\n* Subjects taking steroids\n* Subjects taking beta blockers\n* Subjects on anticoagulant drugs, anemic, or with known bleeding diseases'}, 'identificationModule': {'nctId': 'NCT00592332', 'briefTitle': 'Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2', 'orgStudyIdInfo': {'id': 'IRB#040908-HAAF-T1DM-Q2'}, 'secondaryIdInfos': [{'id': 'DK69803'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1.', 'interventionNames': ['Drug: Alprazolam']}, {'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Hyperinsulinemic glucose clamp in group with no drug.', 'interventionNames': ['Other: control group']}], 'interventions': [{'name': 'Alprazolam', 'type': 'DRUG', 'otherNames': ['Xanax'], 'description': '1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)', 'armGroupLabels': ['2']}, {'name': 'control group', 'type': 'OTHER', 'description': 'control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Stephen N Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department Chair', 'investigatorFullName': 'Steve Davis', 'investigatorAffiliation': 'Vanderbilt University'}}}}