NCT00615368

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 24, 2015

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

February 1, 2008

Last Update Submit

August 20, 2015

Conditions

Type 1 DiabetesHypoglycemia

Keywords

Type 1 diabetesHypoglycaemiaCognitive functionErythropoietin

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    At baseline, during hypoglycemia and after hypoglycemia

Secondary Outcomes (2)

  • Hypoglycaemic counter regulatory symptoms

    At baseline, during hypoglycemia and after hypoglycemia

  • Hypoglycemic hormonal response

    At baseline, during hypoglycemia and after hypoglycemia

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Isotonic NaCl, intravenously injection

Drug: Isotonic NaCl (Placebo)

Active

EXPERIMENTAL

Epoetin alfa, injected

Drug: Epoetin alfa

Interventions

Epoetin alfaDRUG

1 (one) intravenously injection of 40.000 IU epoetin alfa 6 days before induction of experimental hypoglycemia.

Also known as: Eprex
Active
Isotonic NaCl (Placebo)DRUG

1 ml. of isotonic NaCl is intravenously injected 6 days before induction of experimental hypoglycaemia

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes
  • Hypoglycaemia unawareness
  • 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

You may not qualify if:

  • 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)
  • Operation with blood loss within the last 6 weeks
  • Cancer
  • Treated with ciclosporin
  • Suspicion of non-compliance with protocol
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillerød Hospital

Hillerød, Hillerød, 3400, Denmark

Location

Related Publications (1)

  • Kristensen PL, Pedersen-Bjergaard U, Kjaer TW, Olsen NV, Dela F, Holst JJ, Faber J, Tarnow L, Thorsteinsson B. Influence of erythropoietin on cognitive performance during experimental hypoglycemia in patients with type 1 diabetes mellitus: a randomized cross-over trial. PLoS One. 2013;8(4):e59672. doi: 10.1371/journal.pone.0059672. Epub 2013 Apr 5.

    PMID: 23577069DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Peter L Kristensen, MD

    Hillerod Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 1, 2008

First Posted

February 14, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

August 24, 2015

Record last verified: 2015-08

Locations

DK(1)