Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

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

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.

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.

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine
  • 80 mg oral dose, once per day for 6 weeks
• Drug: Placebo
  • 80 mg dose once per day for 6 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Change in level of catecholamines in blood from baseline
  • Time Frame: 6 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: University of Maryland Other

Overall Clinical Trial Officials and Contacts

Stephen N. Davis, MD Principal Investigator University of Maryland  

Overall Contact: Donna Tate, MS 410-706-5643 dtate@medicine.umaryland.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00780650

Study ID Number: HP-00044873

ClinicalTrials.gov Identifier: NCT00780650

Health Authority: United States: Institutional Review Board