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Sponsors and Collaborators: |
Vanderbilt University National Heart, Lung, and Blood Institute (NHLBI) |
Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00600730 |
The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.
Condition | Intervention |
Type 1 Diabetes |
Procedure: Hyperinsulinemic euglycemic clamp with fMRi Procedure: Hyperinsulinemic hypoglycemic clamp study with fMRi |
MedlinePlus related topics: | Diabetes Diabetes Type 1 Exercise and Physical Fitness Hypoglycemia |
Study Type: | Interventional |
Study Design: | Other, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia |
Estimated Enrollment: | 28 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Hyperinsulinemic euglycemic clamp with fMRi
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Procedure: Hyperinsulinemic euglycemic clamp with fMRi
Hyperinsulinemic euglycemic clamp on day 1 with morning fMRi
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2: Experimental
Hyperinsulinemic hypoglycemic clamp with fMRI
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Procedure: Hyperinsulinemic hypoglycemic clamp study with fMRi
Hyperinsulinemic hypoglycemic clamp on day1 with fMRi in morning
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The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain.
During the past decade many studies have shown that appropriate magnetic resonance imaging (MRI) methods may be used to assess alterations in brain regional activation in response to external stimuli or tasks. Thus, this non-invasive technique will enhance our ability to learn more about brain function, during hypoglycemia and may delineate information about the role of the brain in hypoglycemia associated autonomic dysfunction.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Diabetic Subjects:
Exclusion Criteria:
All Subjects
Contact: Donna Tate, MS | 615-936-1824 | donna.tate@vanderbilt.edu |
Vanderbilt University |
National Heart, Lung, and Blood Institute (NHLBI) |
Principal Investigator: | Stephen N Davis, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Stephen N. Davis, MD ) |
Study ID Numbers: | IRB#040025-Brain and Hypo, RO1DK069803-03 |
First Received: | January 14, 2008 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00600730 |
Health Authority: | United States: Institutional Review Board |
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