Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-27 @ 5:12 PM
Study NCT ID:
NCT00780650
Status:
COMPLETED
Last Update Posted:
2019-09-12
First Post:
2008-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
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': 'D000069445', 'term': 'Atomoxetine Hydrochloride'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2008-10-24', 'studyFirstSubmitQcDate': '2008-10-24', 'lastUpdatePostDateStruct': {'date': '2019-09-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in level of catecholamines in blood from baseline', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': "This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat Attention Deficit Hyperactivity Disorder(ADHD) has effects on the body's ability to defend itself against low blood sugar.", 'detailedDescription': "The purpose of this study is to see if the drug atomoxetine (Strattera) has effects on the body's ability to defend itself against low blood sugar. Normally, when blood sugar levels drop below normal, the body creates a series of responses, which increase the sugar inside the body to bring blood sugar levels back to normal. The hormone epinephrine is a key defense against low blood sugar in people with diabetes. Atomoxetine has been shown to increase this hormone level. Thus, any approaches to increase levels of this key defense during low blood sugar may have great value."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals aged 18-50 years\n* Type 1 Diabetes individuals aged 18-50 years\n* BMI \\<40 kg/m2\n* Females of childbearing potential with negative urine pregnancy test\n* Volunteers over 40 years of age, a cardiac stress test with no clinically significant conduction or ischemic changes\n\nExclusion Criteria:\n\nThe following groups of subjects will be excluded from the study:\n\n* Pregnant women\n* Subjects unable to give voluntary informed consent\n* Subjects on anticoagulant drugs or with known bleeding diatheses\n* Subjects with uncontrolled hypertension, heart disease, cerebrovascular incidents\n* Subjects taking MAOIs\n* Subjects with narrow angle glaucoma\n* Subjects with diagnosed psychiatric disorders\n* Subjects with allergy to atomoxetine, heparin, or lidocaine\n\nPhysical Exam Exclusion Criteria:\n\n* Uncontrolled severe hypertension (i.e., blood pressure greater than 150/95)\n* Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmias, ischemic tachycardia, S-T segment deviations, etc.) from history or from cardiac stress testing in subjects \\> 40 years old.\n* Pneumonia\n* Hepatic Failure/Jaundice\n* Renal Failure\n* Acute Cerebrovascular/ Neurological deficit\n* Fever greater than 38.0 C\n\nScreening Laboratory Tests Exclusion Criteria Blood values as defined in protocol'}, 'identificationModule': {'nctId': 'NCT00780650', 'briefTitle': 'Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine', 'orgStudyIdInfo': {'id': 'HP-00044873'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Atomoxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atomoxetine', 'type': 'DRUG', 'otherNames': ['Strattera'], 'description': '80 mg oral dose, once per day for 6 weeks', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '80 mg dose once per day for 6 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Univerisity of Maryland, Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Stephen N. Davis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Stephen N. Davis, MBBS', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}