NCT07374705Recruiting
Disentangling the Effect of Brain Insulin Resistance on Brain Health
Disentangling the Effect of Brain Insulin Resistance on Brain Health (BIR-BrainHealth)
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
People with diabetes are at increased risk of developing dementia, including Alzheimer's disease and vascular dementia. In addition, persons with diabetes have more pronounced age-related brain atrophy and cognitive difficulties compared to people without diabetes. The mechanisms behind the effects on the brain of diabetes are still unclear. New research suggests that the brains of some people with diabetes do not respond normally to insulin signals, a condition known as brain insulin resistance (BIR). To date, there have been no large clinical studies investigating BIR and its impact on brain health, but several smaller studies suggest that BIR may be a cause of cognitive decline and impaired brain health in people with diabetes. Another mechanism that may contribute to impaired brain health in people with diabetes is damage to the blood vessels in the brain. Damage to blood vessels is a well-known complication of diabetes, but how it affects the brain is not fully described. In this project, we will investigate the relationship between BIR and brain blood vessel dysfunction and its relationship to cognition and brain function. This is done by examining patients with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy controls. The participants will undergo MRI brain scans to assess the impact of BIR on the brain physiology and to evaluate brain blood vessel health. Participants will undergo comprehensive assessments of their cognitive abilities and thorough health examination.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 20 Jan 2026
- Start date
- 1 Jan 2026
- Primary completion date
- Oct 2031
- Lead sponsor
- Henrik Bo Wiberg Larsson
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07374705
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Jan 2026 to the primary completion date, Oct 2031
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with drugs that cannot be paused for 12 hours
- Major depression and/or treatment with antipsychotics
- 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)
Other illness
- Other type of diabetes
- Diagnosis of dementia
- Active and recent (1year) malignant disease
- History of major stroke
- 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.)
Lab values
- HbA1c \>100 mmol/mol
- eGFR measurement \<45 within 3 months of study visit
Other
- Weight \>140 Kg
- Severe claustrophobia
- Participants who do not wish to be informed about accidental findings by MRI
Who the study is looking for
- age 50-80 years
- 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
Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup Municipality | Denmark | Recruiting |
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
Related publications
- Disentangling the effect of brain insulin resistance on brain health (BIR-BrainHealth): Rationale and study protocol.Diabet Med · 2026 · PMID 42394131
This page is information, not medical advice. Discuss any trial with your doctor.