NCT00575783

Impact of Hypoglycemia Unawareness on Brain Metabolism Cognition in T1DM

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 51 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The research study is designed to examine the impact of low blood sugar on brain function in individuals with Type 1 Diabetes who have frequent and severe hypoglycemia (low blood sugar) compared to those who do not.

Detailed description

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.

Conditions

• Type 1 Diabetes
• Hypoglycemia

Timeline

• Start date: 2005-08-01
• Completion: 2008-08-01
• First posted: 2007-12-18
• Last updated: 2020-04-02

Locations

1 site across 1 country: United States