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

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Novo Nordisk

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 1
Diabetes

Treatments

Other: glucose clamp

Study type

Interventional

Funder types

Industry

Identifiers

NCT01789593
NN1250-4001
U1111-1131-8749 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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)

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

29 participants in 2 patient groups

Hypoglycaemia / euglycaemia clamp
Other group
Treatment:
Other: glucose clamp
Euglycaemia clamp / hypoglycaemia
Other group
Treatment:
Other: glucose clamp

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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