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Sponsors and Collaborators: |
Vanderbilt University National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00574639 |
The purpose of this study is to determine the way by which Alprazolam (Xanax) an anti-anxiety drug affects specialized molecules in your brain called GABA (A) receptors that alter your body's ability to defend itself from low blood sugar (hypoglycemia). We hypothesize that prior activation of GABA (A) receptors may result in blunting of counterregulatory responses during subsequent hypoglycemia and exercise.
Condition | Intervention |
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Type 1 Diabetes |
Drug: Alprazolam |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Factorial Assignment |
Official Title: | Autonomic Cardiovascular Regulation - Project 5 |
Estimated Enrollment: | 28 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
The ultimate goal of this project is to identify treatments and approaches that will allow patients with diabetes to enjoy all the benefits of good glycemic control without the damaging limitations of severe hypoglycemia. The specific aim of this study is to determine if gamma aminobutyric acid (GABA A) receptors plays a role in the development of exercise associated autonomic dysfunction in type 1 diabetes and healthy man.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Donna B. Tate, MS | 615-936-1824 | donna.tate@vanderbilt.edu |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Donna B. Tate, MS 615-936-1824 donna.tate@vanderbilt.edu | |
Principal Investigator: Stephen N. Davis, MD |
Principal Investigator: | Stephen N. Davis, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Stephen N. Davis, MD ) |
Study ID Numbers: | IRB#070488-Alprazolam-Exercise, HL056693 |
Study First Received: | December 13, 2007 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00574639 History of Changes |
Health Authority: | United States: Institutional Review Board |
Type 1 Diabetes Alprazolam Exercise |
Neurotransmitter Agents Tranquilizing Agents Metabolic Diseases Autoimmune Diseases Psychotropic Drugs Diabetes Mellitus Endocrine System Diseases Central Nervous System Depressants Diabetes Mellitus Type 1 |
Hypoglycemia Alprazolam Diabetes Mellitus, Type 1 Hypnotics and Sedatives Anti-Anxiety Agents Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Neurotransmitter Agents Tranquilizing Agents Metabolic Diseases Autoimmune Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Diabetes Mellitus Endocrine System Diseases |
Central Nervous System Depressants Pharmacologic Actions Alprazolam Diabetes Mellitus, Type 1 Therapeutic Uses Hypnotics and Sedatives GABA Agents Anti-Anxiety Agents Glucose Metabolism Disorders Central Nervous System Agents |