Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Drug: Atomoxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Atomoxetine<br>* 80 mg oral dose, once per day for 6 weeks<br>* Other names: Strattera;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 80 mg dose once per day for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of catecholamines in blood from baseline |  | 6 weeks |