RecruitingNCT07374705

Disentangling the Effect of Brain Insulin Resistance on Brain Health

Disentangling the Effect of Brain Insulin Resistance on Brain Health (BIR-BrainHealth)


Sponsor

Henrik Bo Wiberg Larsson

Enrollment

150 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how insulin resistance in the brain — where brain cells stop responding normally to insulin — may contribute to cognitive decline and brain changes, by studying people with and without diabetes. **You may be eligible if...** - You are between 50 and 80 years old - If you have diabetes: you have had type 1 or type 2 diabetes for at least 5 years (or 10 years for type 1) - Your HbA1c is below 100 mmol/mol - You weigh less than 140 kg **You may NOT be eligible if...** - You have been diagnosed with dementia - You have had a major stroke - You have active cancer diagnosed within the past year - You have severe depression or are taking antipsychotic medications - You have had a traumatic brain injury or conditions like epilepsy - You have severe claustrophobia or metal implants that prevent MRI scanning - Your kidney function is significantly reduced (eGFR below 45) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(3)

Rigshospitalet

Glostrup Municipality, Denmark

Steno Diabetes Center Copenhagen

Herlev, Denmark

University of Ulm

Ulm, Germany

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NCT07374705


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