Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments atomoxetine, placebo
Sponsor University of Maryland
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date May 2009
End date December 2016
Trial size 56 participants
Trial identifier NCT00780650, HP-00044873

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
atomoxetine Strattera
80 mg oral dose, once per day for 6 weeks
(Placebo Comparator)
placebo
80 mg dose once per day for 6 weeks

Primary Outcomes

Measure
Change in level of catecholamines in blood from baseline
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
Principal investigator Stephen N. Davis, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Maryland.