Treatment With Erythropoietin and Cognition During Hypoglycaemia

This study is not yet open for participant recruitment.

Verified by Hillerod Hospital, Denmark, May 2008

Sponsors and Collaborators:	Hillerod Hospital, Denmark 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

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. The next day hypoglycaemia will inducted. Before, during and after hypoglycaemia, the cognitive function will be measured.

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

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Epoetin alfa Erythropoietin

U.S. FDA Resources

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.

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:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
P: Placebo Comparator Isotonic NaCl	Drug: Isotonic NaCl (Placebo) 1 ml. of isotonic NaCl is intravenously injected 6 days before induction of experimental hypoglycaemia
A: Experimental Intravenous erythropoietin	Drug: Epoetin alfa 1 (one) intravenously injection of 40.000 IU epoetin alfa 6 days before induction of experimental hypoglycemia.

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

Contacts

Contact: Peter L Kristensen, MD	+45 48297483	pelk@hih.regionh.dk
Contact: Birger Thorsteinsson, MD, DMSc	+45 48294819	bith@hih.regionh.dk

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

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

Keywords provided by Hillerod Hospital, Denmark:

Type 1 diabetes
Hypoglycaemia
Cognitive function
Erythropoietin

Study placed in the following topic categories:

Epoetin Alfa
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

Additional relevant MeSH terms:

Immune System Diseases
Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009