Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

Type 1 Diabetes Clinical Trial

Official title:

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00780650
• Other study ID #: HP-00044873
• Status: Completed
• Phase: Early Phase 1
• Start date: May 2009
• Est. completion date: August 21, 2018

Study information

• Verified date: September 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: August 21, 2018
• Est. primary completion date: August 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Hypoglycemia
• Primary Dysautonomias
• Type 1 Diabetes

Intervention

Drug:
• Atomoxetine
80 mg oral dose, once per day for 6 weeks
• Placebo
80 mg dose once per day for 6 weeks

Locations

Country	Name	City	State
United States	Univerisity of Maryland, Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in level of catecholamines in blood from baseline		6 weeks