Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1131-8749 | Other Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypoglycaemia / euglycaemia clamp | Other |
| |
| Euglycaemia clamp / hypoglycaemia | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glucose clamp | Other | 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 |
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Ã…rhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29188338 | Result | 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015309 | Glucose Clamp Technique |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |