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Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Miami University of Minnesota |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00575783 |
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.
Condition |
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Type 1 Diabetes Hypoglycemia |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Impact of Hypoglycemia Unawareness on Brain Metabolism Cognition in T1DM |
Estimated Enrollment: | 51 |
Study Start Date: | August 2005 |
Study Completion Date: | August 2008 |
Groups/Cohorts |
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1A, 1B
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 |
2
Type 1 diabetics who are not optimally controlled (>8% HbA1c) and rarely experience hypoglycemia
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3
Healthy non-diabetics
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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.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Group 1A) T1DM subjects with severe hypoglycemia unawareness and awaiting islet cell transplantation will be referred by participating islet transplantation centers.
Group 1B) T1DM subjects with severe hypoglycemia unawareness but not awaiting islet cell transplantation will be from the greater New Haven, CT area.
Group 2)T1DM, not optimally controlled and without hypoglycemia unawareness will be from the greater New Haven, CT area.
Group 3) Non-Diabetics from the greater New Haven CT area.
Inclusion Criteria:
Inclusion Criteria for all subjects:
Inclusion criteria for Group 1A:
Inclusion criteria for Group 1B:
Inclusion criteria for Group 2:
Exclusion Criteria:
Group 1A: (T1DM subjects being considered for islet cell transplantation)
Group 1 B: (T1DM with Severe Hypoglycemia Unawareness not on the Transplant List)
Group 2: (T1DM control subjects)
Group 3: (Normal Controls)
United States, Connecticut | |
Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520 |
Principal Investigator: | Robert Sherwin, MD | Yale University |
Responsible Party: | Yale University School of Medicine ( Robert Sherwin, M.D./Prinicipal Investigator ) |
Study ID Numbers: | DK72409, HIC# 0505000077 |
Study First Received: | December 14, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00575783 History of Changes |
Health Authority: | United States: Federal Government |
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