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Sponsors and Collaborators: |
Hillerod Hospital, Denmark Maastricht University Medical Center Rigshospitalet, Denmark Steno Diabetes Center Panuminstituttet Erasmus Medical Center Aarhus University Hospital |
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Information provided by: | Hillerod Hospital, Denmark |
ClinicalTrials.gov Identifier: | NCT00615368 |
The purpose of the trial is to determine if erythropoietin (EPO) can enhance cognitive function during hypoglycaemia in patients with type 1 diabetes.
Patients with type 1 diabetes will receive one injection of EPO. The next day hypoglycaemia will inducted. Before, during and after hypoglycaemia, the cognitive function will be measured.
Condition | Intervention |
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Type 1 Diabetes Hypoglycemia |
Drug: Epoetin alfa Drug: Isotonic NaCl (Placebo) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | The Effect of Intravenous Erythropoietin Treatment on Cognition During Hypoglycemia in Patients With Type 1 Diabetes. |
Estimated Enrollment: | 12 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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P: Placebo Comparator
Isotonic NaCl
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Drug: Isotonic NaCl (Placebo)
1 ml. of isotonic NaCl is intravenously injected 6 days before induction of experimental hypoglycaemia
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A: Experimental
Intravenous erythropoietin
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Drug: Epoetin alfa
1 (one) intravenously injection of 40.000 IU epoetin alfa 6 days before induction of experimental hypoglycemia.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Peter L Kristensen, MD | +45 48297483 | pelk@hih.regionh.dk |
Contact: Birger Thorsteinsson, MD, DMSc | +45 48294819 | bith@hih.regionh.dk |
Denmark | |
Hillerød Hospital | |
Hillerød, Denmark, 3400 |
Principal Investigator: | Peter L Kristensen, MD | Hillerød Hospital |
Responsible Party: | Hillerød Hospital ( Peter Lommer Kristensen ) |
Study ID Numbers: | 2007-185, EudraCT: 2007-005651-41. |
Study First Received: | February 1, 2008 |
Last Updated: | May 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00615368 |
Health Authority: | Denmark: Danish Medicines Agency; Denmark: Ethics Committee; Denmark: Danish Dataprotection Agency |
Type 1 diabetes Hypoglycaemia Cognitive function Erythropoietin |
Epoetin Alfa Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypoglycemia |
Immune System Diseases Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |