Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Juvenile Diabetes Research Foundation |
---|---|
Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00590876 |
In patients with Type 1 Diabetes Mellitus, hypoglycemia (low blood sugar) is the rate-limiting step to achieve glucose level control. As a result, understanding the body's responses (including the brain's response) to hypoglycemia is essential for the effective treatment of patients with T1DM. The purpose of this research is to determine whether pancreatic islet cell allotransplantation to restore normoglycemia (normal blood glucose levels) in Type
1 Diabetic patients with hypoglycemia unawareness alters brain fuel utilization and cognitive performance under euglycemic (blood sugar at 100 mg/dl) and hypoglycemic (blood sugar at 50 mg/dl) conditions. Three groups of subjects will be studied: (1) T1DM patients with a history of severe hypoglycemia and/or hypoglycemia unawareness who have been selected for pancreatic islet cell allotransplantation; (2) T1DM patients who also have a history of severe hypoglycemia and/or hypoglycemia unawareness; (3) nondiabetic subjects. All subjects will undergo identical testing including: (a) screening; (b) neuropsychological testing; (c) and functional magnetic resonance imaging (fMRI) during euglycemic and hypoglycemic conditions.
Condition |
---|
Diabetes Mellitus, Type 1 |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
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 |
Estimated Enrollment: | 36 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
---|
1
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.
|
2
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.
|
3
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.
|
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Patients undergoing pancreatic islet cell allotransplantation at the University of Minnesota
Patients who are seen at Diabetes Clinics at Yale School of Medicine
Nondiabetic, healthy subjects from New Haven and surrounding communities
Inclusion Criteria:
Exclusion Criteria:
Inclusion criteria for nondiabetic control subjects:
Exclusion criteria for nondiabetic control subjects:
Contact: Robert Sherwin, MD | 203-785-4183 | robert.sherwin@yale.edu |
United States, Connecticut | |
Yale University School of Medicine | Recruiting |
New Haven, Connecticut, United States, 06520 | |
Contact: Robert Sherwin, M.D. 203-785-4183 robert.sherwin@yale.edu | |
Principal Investigator: Robert Sherwin, MD | |
United States, Minnesota | |
University of Minnesota | Not yet recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Bernhard J. Hering, M.D. 612-626-5697 bhering@umn.edu | |
Principal Investigator: Bernhard J. Hering, M.D. |
Principal Investigator: | Robert Sherwin, M.D. | Yale University |
Responsible Party: | Yale School of Medicine ( Robert Sherwin, M.D. ) |
Study ID Numbers: | DK66108a_0304025134, DK20495 |
Study First Received: | December 26, 2007 |
Last Updated: | February 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00590876 History of Changes |
Health Authority: | United States: Federal Government |
Diabetes Mellitus, Type 1 Hypoglycemia Pancreatic Islet Cell Allotransplantation |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Hypoglycemia Metabolic Disorder |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |