Actively Recruiting

Age: 50Years - 80Years
All Genders
Healthy Volunteers
NCT07374705

Disentangling the Effect of Brain Insulin Resistance on Brain Health

Led by Henrik Bo Wiberg Larsson · Updated on 2026-02-25

150

Participants Needed

3

Research Sites

313 weeks

Total Duration

On this page

Sponsors

H

Henrik Bo Wiberg Larsson

Lead Sponsor

S

Steno Diabetes Center Copenhagen

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Disentangling the Effect of Brain Insulin Resistance on Brain Health

Who Can Participate

Age: 50Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 50 and 80 years
  • Diagnosis of type 1 or type 2 diabetes
  • Diabetes duration of at least 10 years for type 1 diabetes
  • Diabetes duration of at least 5 years for type 2 diabetes
Not Eligible

You will not qualify if you...

  • HbA1c greater than 100 mmol/mol
  • Other types of diabetes besides type 1 or type 2
  • Weight over 140 kg
  • Treatment with drugs that cannot be paused for 12 hours
  • Diagnosis of dementia
  • Active or recent malignant disease within the past year
  • History of major stroke
  • Major depression or treatment with antipsychotics
  • History of traumatic brain injury
  • Other medical conditions that prevent following the protocol or pose safety risks
  • Inability to perform neuropsychological tests due to severe vision, hearing impairments, or language barriers
  • Severe claustrophobia
  • Metal foreign bodies preventing MRI scans (e.g., pacemaker, surgical screws or plates in head/neck)
  • Participants who do not want to be informed about accidental MRI findings
  • Estimated glomerular filtration rate (eGFR) below 45 within 3 months before study visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Rigshospitalet

Glostrup Municipality, Denmark, 2600

Actively Recruiting

2

Steno Diabetes Center Copenhagen

Herlev, Denmark, 2730

Actively Recruiting

3

University of Ulm

Ulm, Germany, 89081

Actively Recruiting

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Research Team

H

Henrik BW Larsson, Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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