Clinical Trial

Disentangling the Effect of Brain Insulin Resistance on Brain Health

Study acronym: BIR 1
Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-20.
Trial Details
NCT Number NCT07374705
Lead Sponsor Henrik Bo Wiberg Larsson
Collaborators: Steno Diabetes Center Copenhagen, University of Ulm
Conditions Diabetes Type 2, Diabetes Type 1
Enrollment 150 participants
Start Date 2026-01-01
Primary Completion 2031-10 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-25