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 1Diabetes
- 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
Group Intervention Description Hypoglycaemia / euglycaemia clamp glucose clamp - Euglycaemia clamp / hypoglycaemia glucose clamp -
- Primary Outcome Measures
Name Time Method Digit Symbol Substitution Test (DSST) score Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
- Secondary Outcome Measures
Name Time Method Paced Auditory Serial Addition Task (PASAT) score During recovery from hypoglycaemia and/or euglycaemia measured 75-90 min after euglycaemia has been restored Regional cerebral blood flow (rCBF) score Average 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