Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

Early Phase 1

Completed

• Conditions: Type 1 Diabetes
• Interventions: Drug: Atomoxetine; Drug: Placebo

• Registration Number: NCT00780650
• Lead Sponsor: University of Maryland, Baltimore

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.

Study Timeline

• Study First Submitted: 2008-10-24
• Study First Submitted QC: 2008-10-24
• Study First Posted: 2008-10-27
• Study Start: 2009-05
• Primary Completion: 2018-08-21
• Study Completion: 2018-08-21
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-10
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Atomoxetine	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in level of catecholamines in blood from baseline	6 weeks

Trial Locations

Locations (1)

Univerisity of Maryland, Baltimore; 🇺🇸 Baltimore, Maryland, United States