The Impact of Pancreatic Islet Cell Allotransplantation on Cognitive Function in Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00590876|
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : October 27, 2011
|Condition or disease|
|Diabetes Mellitus, Type 1|
|Study Type :||Observational|
|Estimated Enrollment :||36 participants|
|Official Title:||The Impact of Pancreatic Islet Cell Allotransplantation on Cognitive Function and Brain Fuel Utilization in Patients With Type 1 Diabetes and Hypoglycemia Unawareness|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
T1DM patients with a history of severe hypoglycemia and/or hypoglycemia unawareness who have been selected based upon this history to undergo islet cell transplantation at the University of Minnesota.
T1DM patients (C-peptide negative) who are matched for age, gender, and duration of diabetes, who also have a history of severe hypoglycemia and/or hypoglycemia unawareness meeting the criteria for islet cell transplantation. The hemoglobin A1c for each of these subjects will fall within 1% of the islet transplant recipient to whom they are matched.
Nondiabetic subjects (fasting plasma glucose < 110 mg/dl) who are matched for age and gender to the islet transplant recipient to whom they are matched.
- fMRI [ Time Frame: 0, 3, and 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590876
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Robert Sherwin, M.D.||Yale University|