Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780650
Recruitment Status : Active, not recruiting
First Posted : October 27, 2008
Last Update Posted : February 16, 2018
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Stephen N. Davis, MBBS, University of Maryland

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Atomoxetine Drug: Placebo Early Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine
Study Start Date : May 2009
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: Atomoxetine
80 mg oral dose, once per day for 6 weeks
Other Name: Strattera
Placebo Comparator: 2 Drug: Placebo
80 mg dose once per day for 6 weeks

Primary Outcome Measures :
  1. Change in level of catecholamines in blood from baseline [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00780650

United States, Maryland
Univerisity of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Stephen N. Davis, MD University of Maryland

Responsible Party: Stephen N. Davis, MBBS, Professor, University of Maryland Identifier: NCT00780650     History of Changes
Other Study ID Numbers: HP-00044873
First Posted: October 27, 2008    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autonomic Nervous System Diseases
Primary Dysautonomias
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Nervous System Diseases
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs