Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

• Status: Completed
• Trial end date: 2018-08-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Atomoxetine Hydrochloride

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