Treatment With Erythropoietin and Cognition During Hypoglycaemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Hillerod Hospital, Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Maastricht University Medical Center
Rigshospitalet, Denmark
Steno Diabetes Center
Panuminstituttet
Erasmus Medical Center
Aarhus University Hospital
Information provided by:
Hillerod Hospital, Denmark
ClinicalTrials.gov Identifier:
NCT00615368
First received: February 1, 2008
Last updated: May 28, 2010
Last verified: November 2009
  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, during and after 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
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 ]

Estimated Enrollment: 12
Study Start Date: May 2008
Estimated Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: P
Isotonic NaCl
Drug: Isotonic NaCl (Placebo)
1 ml. of isotonic NaCl is intravenously injected 6 days before induction of experimental hypoglycaemia
Experimental: A
Intravenous erythropoietin
Drug: Epoetin alfa
1 (one) intravenously injection of 40.000 IU epoetin alfa 6 days before induction of experimental hypoglycemia.
Other Name: Eprex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615368

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

No publications provided by Hillerod Hospital, Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Lommer Kristensen, Hillerød Hospital
ClinicalTrials.gov Identifier: NCT00615368     History of Changes
Other Study ID Numbers: 2007-185, EudraCT: 2007-005651-41.
Study First Received: February 1, 2008
Last Updated: May 28, 2010
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014