Status:
COMPLETED
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-50 years
Phase:
EARLY_PHASE1
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 ...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 21 2018
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00780650
Start Date
May 1 2009
End Date
August 21 2018
Last Update
September 12 2019
Active Locations (1)
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1
Univerisity of Maryland, Baltimore
Baltimore, Maryland, United States, 21201