Back to resultsA Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
glucose clamp
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes
Eligibility 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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Hypoglycaemia / euglycaemia clamp
Euglycaemia clamp / hypoglycaemia
Arm Description
Outcomes
Primary Outcome Measures
Digit Symbol Substitution Test (DSST) score
Secondary Outcome Measures
Regional cerebral blood flow (rCBF) score
Paced Auditory Serial Addition Task (PASAT) score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01789593
Brief Title
A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
Official Title
A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 14, 2013 (Actual)
Primary Completion Date
December 1, 2013 (Actual)
Study Completion Date
December 1, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypoglycaemia / euglycaemia clamp
Arm Type
Other
Arm Title
Euglycaemia clamp / hypoglycaemia
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
glucose clamp
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Århus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
29188338
Citation
Gejl M, Gjedde A, Brock B, Moller A, van Duinkerken E, Haahr HL, Hansen CT, Chu PL, Stender-Petersen KL, Rungby J. Effects of hypoglycaemia on working memory and regional cerebral blood flow in type 1 diabetes: a randomised, crossover trial. Diabetologia. 2018 Mar;61(3):551-561. doi: 10.1007/s00125-017-4502-1. Epub 2017 Nov 29.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
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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