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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01789593

Enrollment

Registered

2013-02-12

Start date

2013-01-14

Completion date

2013-12-01

Last updated

2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

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.

Interventions

OTHERglucose clamp

Each subject will be randomly allocated to an experimental visit sequence consisting of a hypoglycaemic glucose clamp followed by euglycaemic glucose clamp (using i.v. infusion of human soluble insulin (Actrapid®)) or vice versa separated by at least 21 days. Each visit includes an overnight stay. For each of the two conditions (euglycaemia and hypoglycaemia) cognitive performance will be assessed by a validated cognitive test

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Regional cerebral blood flow (rCBF) score	Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
Paced Auditory Serial Addition Task (PASAT) score	During recovery from hypoglycaemia and/or euglycaemia measured 75-90 min after euglycaemia has been restored

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026