Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery
The purpose of this study is to find out the effects of hypoglycemia on cognition in healthy individuals and how well changes in (interstitial) tissue glucose levels correlate with changes in cognitive function as compared to blood glucose levels.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Blood/Interstitial Glucose Measurements and Cognitive Function During Hypoglycemia and Recovery|
- cognitive function correlation to blood or interstitial glucose [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]This investigator initiated study will evaluate cognitive function at the onset, during and following recovery from hypoglycemia and will determine if cognitive function correlates better with blood or interstitial glucose concentrations.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Subjects will complete clamp study visit.
Procedure: euglycemic and hypoglycemic clamp
Subjects will undergo standard euglycemic and hypoglycemic clamps, and will have concurrent assessments of cognitive function and measurement of interstitial glucose concentrations.
Subjects will undergo hypoglycemic clamps during which interstitial glucose will be measured and cognitive function will be assessed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01283126
|Contact: Astrid Atakov Castillo, BA||617-309-1997||Astrid.Atakov-Castillo@joslin.harvard.edu|
|United States, Massachusetts|
|Joslin Diabetes Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Astrid Atakov Castillo, BA 617-309-1997 Astrid.Atakov-Castillo@joslin.harvard.edu|
|Principal Investigator: Howard Wolpert, MD|
|Sub-Investigator: Greeshma K Shetty, MD|
|Sub-Investigator: Gail Musen, PhD|
|Sub-Investigator: Gail Adler, MD, PhD|
|Principal Investigator:||Howard Wolpert, MD||Joslin Diabetes Center|
|Study Chair:||Greeshma K Shetty, MD||Joslin Diabetes Center|
|Study Chair:||Gail Musen, PhD||Joslin Diabetes Center|
|Study Chair:||Gail Adler, MD, PhD||Brigham and Women's Hospital|