Brain insulin resistance and brain health in people with diabetes
Disentangling the Effect of Brain Insulin Resistance on Brain Health (BIR-BrainHealth)
This project will test whether brains that don't respond well to insulin in people aged 50–80 with type 1 or type 2 diabetes are linked to worse thinking and structural brain changes compared with people without diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 3 sites (Glostrup Municipality and 2 other locations) |
| Trial ID | NCT07374705 on ClinicalTrials.gov |
What this trial studies
The multicenter project uses cognitive testing, advanced MRI scans, metabolic profiling, and multi-omics to explore whether brain insulin resistance (BIR) and cerebrovascular damage explain cognitive decline in diabetes. This registration covers the MRI components; PET imaging is not included here. The study plans to enroll about 50 people with type 1 diabetes, 50 with type 2 diabetes, and 50 control participants across sites in Denmark and Germany. Participants will be aged 50–80 and meet prespecified diabetes duration and safety criteria.
Who should consider this trial
Good fit: Ideal candidates are people aged 50–80 with type 1 diabetes for at least 10 years or type 2 diabetes for at least 5 years who do not have dementia and meet the trial's safety and MRI eligibility criteria.
Not a fit: People with diagnosed dementia, recent major stroke, active recent cancer, uncontrolled psychiatric illness, severe sensory impairment, weight over 140 kg, or who cannot pause certain medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the work could help identify patients at higher risk of cognitive decline and point to new prevention or treatment targets for diabetes-related brain problems.
How similar studies have performed: Smaller prior studies have suggested a link between brain insulin resistance and cognitive decline, but no large MRI-focused multicenter studies have yet confirmed this relationship.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (all): * age 50-80 years Inclusion Criteria (diabetes only): * Diagnosis of either type 1 diabetes or type 2 diabetes * Diabetes duration of ≥10 years for individuals with type 1 diabetes and ≥5 years for individuals with type 2 diabetes Exclusion Criteria: * HbA1c \>100 mmol/mol * Other type of diabetes * Weight \>140 Kg * Treatment with drugs that cannot be paused for 12 hours * Diagnosis of dementia * Active and recent (1year) malignant disease * History of major stroke * Major depression and/or treatment with antipsychotics * History of traumatic brain injury * 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. * 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.) * Severe claustrophobia * 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) * Participants who do not wish to be informed about accidental findings by MRI * eGFR measurement \<45 within 3 months of study visit
Where this trial is running
Glostrup Municipality and 2 other locations
- Rigshospitalet — Glostrup Municipality, Denmark (Recruiting)
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)
- University of Ulm — Ulm, Germany (Recruiting)
Study contacts
- Principal investigator: Henrik BW Larsson, Professor — Rigshospitalet, Denmark
- Study coordinator: Henrik BW Larsson, Professor
- Email: henrik.bo.wiberg.larsson@regionh.dk
- Phone: +45 24824294
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.