Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

University of Maryland Baltimore (UMB)

Status and phase

Completed

Early Phase 1

Conditions

Type 1 Diabetes

Treatments

Drug: Placebo

Drug: Atomoxetine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00780650

HP-00044873

Details and patient eligibility

About

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.

Full description

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.

Enrollment

56 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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