Treatment With Erythropoietin and Cognition During Hypoglycaemia

This study has been completed.
Maastricht University Medical Center
Rigshospitalet, Denmark
Steno Diabetes Center
Erasmus Medical Center
Aarhus University Hospital
Information provided by (Responsible Party):
Peter Lommer Kristensen, Hillerod Hospital, Denmark Identifier:
First received: February 1, 2008
Last updated: August 20, 2015
Last verified: August 2015

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. Hypoglycaemia will be induced 6 days after. Before (1 hour), during and after (1 hour) hypoglycaemia, the cognitive function will be measured.

Condition Intervention
Type 1 Diabetes
Drug: Epoetin alfa
Drug: Isotonic NaCl (Placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Intravenous Erythropoietin Treatment on Cognition During Hypoglycemia in Patients With Type 1 Diabetes.

Resource links provided by NLM:

Further study details as provided by Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Cognitive function [ Time Frame: At baseline, during hypoglycemia and after hypoglycemia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypoglycaemic counter regulatory symptoms [ Time Frame: At baseline, during hypoglycemia and after hypoglycemia ] [ Designated as safety issue: No ]
  • Hypoglycemic hormonal response [ Time Frame: At baseline, during hypoglycemia and after hypoglycemia ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2008
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Isotonic NaCl, intravenously injection
Drug: Isotonic NaCl (Placebo)
1 ml. of isotonic NaCl is intravenously injected 6 days before induction of experimental hypoglycaemia
Experimental: Active
Epoetin alfa, injected
Drug: Epoetin alfa
1 (one) intravenously injection of 40.000 IU epoetin alfa 6 days before induction of experimental hypoglycemia.
Other Name: Eprex

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Type 1 diabetes
  • Hypoglycaemia unawareness
  • 2 or more episodes of hypoglycaemia in the last 12 months
  • Age >18 år
  • Duration of diabetes > 5 år
  • Weight > 50 kg
  • No pregnancy
  • Informed consent

Exclusion Criteria:

  • Pregnancy
  • Heart failure (NYHA 2-4)
  • Ischaemic heart disease
  • Epilepsy
  • Venous thromboembolic disease
  • Thrombocytosis
  • Beta receptor antagonists
  • Disturbance of vision
  • History of stroke
  • History of erythropoietin treatment
  • Plasma-creatinin > 100 umol/l (male)or 88 umol/l (female)
  • Plasma-haemoglobin < 7,0 or > 11 mmol/l at time of inclusion
  • Operation with blood loss within the last 6 weeks
  • Cancer
  • Treated with ciclosporin
  • Suspicion of non-compliance with protocol
  • Conditions incompatible with participation - e.g. safety considerations.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00615368

Hillerød Hospital
Hillerød, Denmark, 3400
Sponsors and Collaborators
Hillerod Hospital, Denmark
Maastricht University Medical Center
Rigshospitalet, Denmark
Steno Diabetes Center
Erasmus Medical Center
Aarhus University Hospital
Principal Investigator: Peter L Kristensen, MD Hillerod Hospital, Denmark
  More Information

No publications provided by Hillerod Hospital, Denmark

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peter Lommer Kristensen, MD, Hillerod Hospital, Denmark Identifier: NCT00615368     History of Changes
Other Study ID Numbers: 2007-185, 2007-005651-41, H-A-2007-0116
Study First Received: February 1, 2008
Last Updated: August 20, 2015
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by Hillerod Hospital, Denmark:
Type 1 diabetes
Cognitive function

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Epoetin alfa
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on November 25, 2015