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Treatment With Erythropoietin and Cognition During Hypoglycaemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00615368
First Posted: February 14, 2008
Last Update Posted: August 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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
  Purpose

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 Hypoglycemia Drug: Epoetin alfa Drug: Isotonic NaCl (Placebo)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 Peter Lommer Kristensen, Hillerod Hospital, Denmark:

Primary Outcome Measures:
  • Cognitive function [ Time Frame: At baseline, during hypoglycemia and after hypoglycemia ]

Secondary Outcome Measures:
  • Hypoglycaemic counter regulatory symptoms [ Time Frame: At baseline, during hypoglycemia and after hypoglycemia ]
  • Hypoglycemic hormonal response [ Time Frame: At baseline, during hypoglycemia and after hypoglycemia ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615368


Locations
Denmark
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
Investigators
Principal Investigator: Peter L Kristensen, MD Hillerod Hospital, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Lommer Kristensen, MD, Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier: NCT00615368     History of Changes
Other Study ID Numbers: 2007-185
2007-005651-41 ( EudraCT Number )
H-A-2007-0116 ( Other Identifier: The Regional Committee on Biomedical Research Ethics )
First Submitted: February 1, 2008
First Posted: February 14, 2008
Last Update Posted: August 24, 2015
Last Verified: August 2015

Keywords provided by Peter Lommer Kristensen, Hillerod Hospital, Denmark:
Type 1 diabetes
Hypoglycaemia
Cognitive function
Erythropoietin

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Epoetin Alfa
Hematinics