Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Stephen N. Davis, University of Maryland
ClinicalTrials.gov Identifier:
NCT00780650
First received: October 24, 2008
Last updated: May 24, 2016
Last verified: May 2016
  Purpose
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 Intervention
Type 1 Diabetes
Drug: Atomoxetine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Change in level of catecholamines in blood from baseline [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: May 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780650

Locations
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)
Investigators
Principal Investigator: Stephen N. Davis, MD University of Maryland
  More Information

Responsible Party: Stephen N. Davis, Professor, University of Maryland
ClinicalTrials.gov Identifier: NCT00780650     History of Changes
Other Study ID Numbers: HP-00044873 
Study First Received: October 24, 2008
Last Updated: May 24, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
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

ClinicalTrials.gov processed this record on August 25, 2016