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A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes

Phase 1
Completed
Conditions
Diabetes Mellitus, Type 1
Diabetes
Interventions
Other: glucose clamp
Registration Number
NCT01789593
Lead Sponsor
Novo Nordisk A/S
Brief Summary

This trial is conducted in Europe. The aim of the trial is to compare cognitive function and associated brain activation patterns during an acute hypoglycaemic episode and during euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in subjects with type 1 diabetes.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
29
Inclusion Criteria
  • Right-handed subjects
  • Type 1 diabetes mellitus for at least 12 months
  • Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
  • Body mass index 18.0-28.0 kg/m^2 (both inclusive)
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Exclusion Criteria
  • Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
  • Current tobacco user (any smoking or use of nicotinic products within 3 months prior to screening)
  • Visual impairment or auditory impairment
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Hypoglycaemia / euglycaemia clampglucose clamp-
Euglycaemia clamp / hypoglycaemiaglucose clamp-
Primary Outcome Measures
NameTimeMethod
Digit Symbol Substitution Test (DSST) scoreAverage score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
Secondary Outcome Measures
NameTimeMethod
Paced Auditory Serial Addition Task (PASAT) scoreDuring recovery from hypoglycaemia and/or euglycaemia measured 75-90 min after euglycaemia has been restored
Regional cerebral blood flow (rCBF) scoreAverage score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia

Trial Locations

Locations (1)

Novo Nordisk Investigational Site

🇩🇰

Århus C, Denmark

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