Treatment With Erythropoietin and Cognition During Hypoglycaemia

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00615368
First received: February 1, 2008
Last updated: August 20, 2015
Last verified: August 2015
  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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Erasmus Medical Center
Aarhus University Hospital
Investigators
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 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, 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
Hypoglycaemia
Cognitive function
Erythropoietin

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

ClinicalTrials.gov processed this record on September 03, 2015