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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

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ClinicalTrials.gov Identifier: NCT01789593
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Other: glucose clamp Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
Actual Study Start Date : January 14, 2013
Primary Completion Date : December 1, 2013
Study Completion Date : December 1, 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Hypoglycaemia / euglycaemia clamp Other: glucose 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
Euglycaemia clamp / hypoglycaemia Other: glucose 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


Outcome Measures

Primary Outcome Measures :
  1. Digit Symbol Substitution Test (DSST) score [ Time Frame: Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia ]

Secondary Outcome Measures :
  1. Regional cerebral blood flow (rCBF) score [ Time Frame: Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia ]
  2. Paced Auditory Serial Addition Task (PASAT) score [ Time Frame: During recovery from hypoglycaemia and/or euglycaemia measured 75-90 min after euglycaemia has been restored ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01789593


Locations
Denmark
Novo Nordisk Investigational Site
Århus C, Denmark, 8000
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01789593     History of Changes
Other Study ID Numbers: NN1250-4001
U1111-1131-8749 ( Other Identifier: WHO )
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases