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Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

This study is currently Recruiting

February 2011 By University of Maryland

First Recieved on October 24, 2008

Last Updated on February 7, 2011

Sponsor: University of Maryland
Collaborators:
Information provided by: University of Maryland
Identifier: NCT00780650

Purpose

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.

Study Type: Interventional
Study Design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:Accepts Healthy Volunteers
Criteria

Inclusion Criteria: - Healthy individuals aged 18-50 years - Type 1 Diabetes individuals aged 18-50 years - BMI <40 kg/m2 - Females of childbearing potential with negative urine pregnancy test - Volunteers over 40 years of age, a cardiac stress test with no clinically significant conduction or ischemic changes Exclusion Criteria: The following groups of subjects will be excluded from the study: - Pregnant women - Subjects unable to give voluntary informed consent - Subjects on anticoagulant drugs or with known bleeding diatheses - Subjects with uncontrolled hypertension, heart disease, cerebrovascular incidents - Subjects taking MAOIs - Subjects with narrow angle glaucoma - Subjects with diagnosed psychiatric disorders - Subjects with allergy to atomoxetine, heparin, or lidocaine Physical Exam Exclusion Criteria: - Uncontrolled severe hypertension (i.e., blood pressure greater than 150/95) - 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. - Pneumonia - Hepatic Failure/Jaundice - Renal Failure - Acute Cerebrovascular/ Neurological deficit - Fever greater than 38.0 C Screening Laboratory Tests Exclusion Criteria Blood values as defined in protocol

Investigators

  • Investigator: Stephen N. Davis, MD - Principal Investigator - University of Maryland

Locations

  • Univerisity of Maryland, Baltimore

    Baltimore, Maryland 21201 United States

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