Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q4-Atomoxetine - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00780650

Purpose

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
Type 1 Diabetes	Drug: Atomoxetine Drug: Placebo

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

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

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Catecholamines [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Atomoxetine 80 mg oral dose, once per day for 6 weeks
2: Placebo Comparator	Drug: Placebo 80 mg dose once per day for 6 weeks

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy, male and female individuals aged 18-50 years
Type 1 Diabetes, male and female individuals aged 18-50 years
BMI <40 kg/m2
Females of childbearing potential with negative HCG pregnancy test

Exclusion Criteria:

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, liver or kidney disease

Physical Exam Exclusion Criteria

Blood Pressure greater than 150/95
Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia)
Pneumonia
Hepatic Failure/Jaundice
Renal Failure
Acute Cerebrovascular/ Neurological deficit
Fever greater than 39.0 C

Screening Laboratory Tests Exclusion Criteria

Hemoglobin value below 10.5g/dl and above 18.5g/dl
WBC lower than 3 thou/ul or greater than 14 thou/ul
Liver Function Tests: SGOT and SGPT greater than twice upper limit of normal range (i.e. greater than 80 U/L)
TBil greater than 2 mg/dl
Alkaline Phosphatase greater than 150U/L
Creatinine greater than 1.6mg/dl

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	VAnderbilt University ( Stephen N. Davis, MD )
Study ID Numbers:	080964
Study First Received:	October 24, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00780650
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Atomoxetine

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

Immune System Diseases
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009