Impact of Hypoglycemia Unawareness on Brain Metabolism Cognition in T1DM
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|ClinicalTrials.gov Identifier: NCT00575783|
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : January 26, 2012
|Condition or disease|
|Type 1 Diabetes Hypoglycemia|
During the course of treating diabetes (for example, after an insulin injection), blood sugar levels will sometimes drop too low. This condition is known as hypoglycemia. Normally, a healthy body responds to hypoglycemia by producing a number of "anti-insulin" hormones which raise blood sugar levels. In addition, these hormones provide the individual with warning signals of hypoglycemia, including hunger, sweating, shaking and heart palpitations. These warning signals allow diabetics to correct low blood sugar levels by eating sugar tablets or by having a snack.
Unfortunately, and for unclear reasons, many people with longstanding diabetes lose their ability to recognize low blood sugar levels-a condition called "hypoglycemia unawareness." The brain, in particular, is extremely sensitive to hypoglycemia. Unable to sense and respond to low blood sugar levels, these individuals may experience a sudden onset of blurred vision, confusion, seizures, coma, or even death.
In recent years, a new technique called "islet cell transplantation" has been developed as an alternate means of treating insulin-dependent diabetes. Pancreatic islet cells (the cells that produce insulin), from human donors, are injected into the diabetic patient's liver where the cells are capable of making insulin and can regulate blood sugar levels without the need for insulin injections. Currently, this technique is used primarily in patients with severe hypoglycemia unawareness.
While it is known that islet cell transplantation can reduce the risk of severe hypoglycemia, the effects of transplantation on hypoglycemia unawareness are unknown. This study is designed to investigate why hypoglycemia unawareness happens and the impact it has on brain function in individuals with type 1 diabetes.
|Study Type :||Observational|
|Estimated Enrollment :||51 participants|
|Observational Model:||Case Control|
|Official Title:||Impact of Hypoglycemia Unawareness on Brain Metabolism Cognition in T1DM|
|Study Start Date :||August 2005|
|Study Completion Date :||August 2008|
Type 1 diabetic subjects with a history of severe hypoglycemia and hypoglycemia unawareness who:
1A) meet criteria for islet cell transplantation and are referred by a participating islet cell transplantation center
1B) meet similar criteria but are not currently planning islet cell transplantation
Type 1 diabetics who are not optimally controlled (>8% HbA1c) and rarely experience hypoglycemia
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): NCT00575783
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520|
|Principal Investigator:||Robert Sherwin, MD||Yale University|