Diabetes type 1 and diabetes type 2 Nutritional, Metabolic, Endocrine
Conditions
Interventions
All participants will undergo a comprehensive clinical evaluation to characterize diabetes duration, severity, and systemic comorbidities.
The cognitive performance of the participants will be assesse
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Type 1 diabetes with a duration of =10 years 2. Type 2 diabetes with a duration of =5 years 3. Healthy controls
Exclusion criteria
Exclusion criteria: 1. HbA1c >100 mmol/mol 2. Other type of diabetes 3. Weight >140 Kg 4. Treatment with drugs that cannot be paused for 12 hours 5. Diagnosis of dementia 6. Active and recent (1year) malignant disease 7. History of major stroke 8. Major depression and/or treatment with antipsychotics 9. History of traumatic brain injury 10. Other medical condition or disorder (e.g., epilepsy, recent concussion) that in the opinion of the investigator precludes compliance with the protocol, evaluation of the results or represent an unacceptable risk for the participant’s safety. 11. Inability to perform neuropsychological tests (e.g., severe vision and hearing impairment that cannot be improved with aids such as glasses and hearing aids, or language barrier.) 12. Severe claustrophobia 13. Foreign bodies of metal in the body which prohibits brain MRI scans (e.g. pacemaker or screws/plates from surgery in the head or neck region) 14. Participants who do not wish to be informed about accidental findings by MRI 15. eGFR measurement <45 within 3 months of study visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Brain insulin response is measured using changes in cerebral blood flow assessed by arterial spin labelling (ASL) MRI following intranasal insulin administration at baseline 2. Cerebrovascular reactivity is measured using changes in cerebral blood flow responses to inhalation of hypercapnic air assessed by blood-oxygen-level-dependent (BOLD) MRI, arterial spin labelling (ASL) MRI, and phase contrast mapping (PCM) MRI at baseline 3. Verbal learning is measured using the Rey Auditory Verbal Learning Test (RAVLT) at baseline 4. Processing speed and executive function are measured using the Trail Making Test (TMT) part A and B at baseline 5. Attention and processing speed are measured using the Symbol Digit Modalities Test (SDMT) at baseline 6. Working memory is measured using the RBANS Digit Span forward (Version A) at baseline 7. Working memory and sequencing ability are measured using the Wechsler Adult Intelligence Scale III Letter-Number Sequencing test (WAIS-LNS) at baseline 8. Verbal fluency is measured using the Verbal Fluency test (phonetic and semantic) at baseline 9. Sustained attention is measured using the Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automated Battery (CANTAB), using A' (RVP-A) and mean latency for correct responses at baseline 10. Motor function is measured using the Grooved Pegboard test at baseline 11. Global cognitive function is measured using the Montreal Cognitive Assessment (MoCA) at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood-brain-barrier permeability is measured using dynamic contrast enhanced MRI at baseline 2. Neurovascular coupling is measured using cerebral blood flow responses to visual stimulation assessed by ASL MRI at baseline 3. Hypothalamic glucose sensing is measured using cerebral blood flow response in the hypothalamus to glucose ingestion assessed by combined BOLD and ASL MRI at baseline 4. Brain insulin response is measured using changes in cerebral blood flow following intranasal insulin administration assessed by ASL MRI at baseline 5. Cerebrovascular reactivity is measured using changes in cerebral blood flow in response to inhalation of hypercapnic air assessed by BOLD MRI, ASL MRI, and phase contrast mapping (PCM) MRI at baseline 6. Brain atrophy is measured using T1-weighted structural MRI at baseline 7. White matter lesion load is measured using Fluid-Attenuated Inversion Recovery (FLAIR) MRI at baseline 8. Cerebral microbleeds are measured using susceptibility-weighted MRI at baseline 9. Structural connectivity is measured using diffusion tensor imaging (DTI) MRI at baseline 10. White matter diffusion integrity is measured using DTI MRI at baseline 11. White matter diffusion is measured using DTI MRI at baseline 12. Resting cerebral blood flow is measured using ASL MRI and PCM MRI at baseline 13. Cerebral metabolic rate of oxygen is measured using PCM MRI and susceptibility-based oximetry (SBO) MRI at baseline 14. Regional brain glucose sensing is measured using cerebral blood flow response to glucose ingestion assessed by combined BOLD and ASL MRI at baseline 15. Cerebral blood flow response in the hypothalamus to glucose ingestion is measured using combined BOLD and ASL MRI at baseline 16. Brain insulin sensing biomarkers are measured using a multiomics approach integrating lipidomics, metabolomics, proteomics, transcriptomics, and genotyping at baseline 17. Brain insulin response is measured using changes in cerebral bl | — |
Countries
Denmark, Germany
Contacts
Public ContactNicole Jacqueline Jensen
Outcome results
None listed