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Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine - NCT00780650-37232(Clinical Trial 249371)



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City:  Nashville
State:  
TN
Zip Code: 37232
Conditions: Type 1 Diabetes
Purpose: This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat ADHD) has effects on the body's ability to defend itself against low blood sugar.
Study summary: To date, there are no studies investigating the effects of NET transporter inhibition during hypoglycemia. Although Swanson et al. have recently demonstrated that atomoxetine can inhibit norepinephrine reuptake transport in the hypothalamus and hippocampus, two important areas in regulating the ANS counterregulatory responses to hypoglycemia. Thus, blocking NET transport during hypoglycemia presents the intriguing possibility that this approach may amplify ANS and particularly epinephrine levels during hypoglycemia. Therefore, the aim of this study is to determine if selective inhibition of norepinephrine reuptake can increase ANS responses during repeated hypoglycemia in healthy man.
Criteria: Inclusion Criteria: - Healthy, male and female individuals aged 18-50 years - Type 1 Diabetes, male and female individuals aged 18-50 years - BMI <40 kg/m2 - Females of childbearing potential with negative HCG pregnancy test Exclusion Criteria: - 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, liver or kidney disease Physical Exam Exclusion Criteria - Blood Pressure greater than 150/95 - Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia) - Pneumonia - Hepatic Failure/Jaundice - Renal Failure - Acute Cerebrovascular/ Neurological deficit - Fever greater than 39.0 C Screening Laboratory Tests Exclusion Criteria - Hemoglobin value below 10.5g/dl and above 18.5g/dl - WBC lower than 3 thou/ul or greater than 14 thou/ul - Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L) - TBil greater than 2 mg/dl - Alkaline Phosphatase greater than 150U/L - Creatinine greater than 1.6mg/dl
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Data Source: ClinicalTrials.gov
Date Processed: January 5, 2011
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