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Tracking Information | |||||
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First Received Date † | January 14, 2008 | ||||
Last Updated Date | March 4, 2009 | ||||
Start Date † | January 2009 | ||||
Current Primary Outcome Measures † |
fMRi scans [ Time Frame: 1 day ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00600730 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia | ||||
Official Title † | The Effects of Antecedent Hypoglycemia or Exercise on the Response of the Brain to Subsequent Hypoglycemia | ||||
Brief Summary | The studies proposed in this application seek to use non-invasive techniques to examine the impact of repeated hypoglycemia on the brain. |
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Detailed Description | 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. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Other, Randomized, Open Label, Active Control, Parallel Assignment | ||||
Condition † | Type 1 Diabetes | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Withdrawn | ||||
Estimated Enrollment † | 28 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Diabetic Subjects:
Exclusion Criteria: All Subjects
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Gender | Both | ||||
Ages | 18 Years to 45 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00600730 | ||||
Responsible Party | Stephen N. Davis, MD, Vanderbilt University | ||||
Secondary IDs †† | RO1DK069803-03 | ||||
Study Sponsor † | Vanderbilt University | ||||
Collaborators †† | National Heart, Lung, and Blood Institute (NHLBI) | ||||
Investigators † |
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Information Provided By | Vanderbilt University | ||||
Verification Date | March 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |