Treatment With Erythropoietin and Cognition During Hypoglycaemia

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hillerod Hospital, Denmark
• Collaborators: Aarhus University Hospital; Erasmus Medical Center; Maastricht University Medical Center; Rigshospitalet, Denmark; Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Treatments: Epoetin Alfa

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.