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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00780650 |
This study is aimed at determining if the drug Atomoxetine (Strattera-used to treat ADHD) has effects on the body's ability to defend itself against low blood sugar.
Condition | Intervention |
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Type 1 Diabetes |
Drug: Atomoxetine Drug: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment |
Official Title: | Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine |
Estimated Enrollment: | 48 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Atomoxetine
80 mg oral dose, once per day for 6 weeks
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2: Placebo Comparator |
Drug: Placebo
80 mg dose once per day for 6 weeks
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To date, there are no studies investigating the effects of NET transporter inhibition during hypoglycemia.
Although Swanson et al. have recently demonstrated that atomoxetine can inhibit norepinephrine reuptake transport in the hypothalamus and hippocampus, two important areas in regulating the ANS counterregulatory responses to hypoglycemia. Thus, blocking NET transport during hypoglycemia presents the intriguing possibility that this approach may amplify ANS and particularly epinephrine levels during hypoglycemia. Therefore, the aim of this study is to determine if selective inhibition of norepinephrine reuptake can increase ANS responses during repeated hypoglycemia in healthy man.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Physical Exam Exclusion Criteria
Screening Laboratory Tests Exclusion Criteria
United States, Tennessee | |
Vanderbilt Univerisity | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Vanessa Briscoe, PhD, NP 615-936-1824 vanessa.j.briscoe@vanderbilt.edu | |
Contact: Donna Tate, MS 615-936-1824 donna.tate@vanderbilt.edu |
Responsible Party: | VAnderbilt University ( Stephen N. Davis, MD ) |
Study ID Numbers: | 080964 |
Study First Received: | October 24, 2008 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00780650 History of Changes |
Health Authority: | United States: Institutional Review Board |
Neurotransmitter Agents Metabolic Diseases Autoimmune Diseases Adrenergic Agents Diabetes Mellitus Endocrine System Diseases Atomoxetine |
Diabetes Mellitus Type 1 Hypoglycemia Diabetes Mellitus, Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Metabolic Diseases Autoimmune Diseases Immune System Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Adrenergic Uptake Inhibitors |
Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Atomoxetine Hypoglycemia Pharmacologic Actions Diabetes Mellitus, Type 1 Glucose Metabolism Disorders |