Clinical trial NCT00780650: Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
Official title: Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-10-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in level of catecholamines in blood from baseline
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Univerisity of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Stephen N. Davis, MD
role: PRINCIPAL_INVESTIGATOR
References: