Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started May 2009
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 24, 2008
CompletedFirst Posted
Study publicly available on registry
October 27, 2008
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 21, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2018
CompletedSeptember 12, 2019
September 1, 2019
9.3 years
October 24, 2008
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in level of catecholamines in blood from baseline
6 weeks
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Univerisity of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephen N. Davis, MD
University of Maryland, Baltimore
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 24, 2008
First Posted
October 27, 2008
Study Start
May 1, 2009
Primary Completion
August 21, 2018
Study Completion
August 21, 2018
Last Updated
September 12, 2019
Record last verified: 2019-09