Actively Recruiting
Disentangling the Effect of Brain Insulin Resistance on Brain Health (BIR-BrainHealth)
Led by Henrik Bo Wiberg Larsson · Updated on 2026-02-25
150
Participants Needed
3
Research Sites
13 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
Researchers are investigating how brain insulin resistance (BIR) may contribute to cognitive decline and dementia risk in people with diabetes. The study focuses on participants with type 1 diabetes, type 2 diabetes, and healthy controls aged 50 to 80 years. It aims to understand the link between BIR, brain blood vessel dysfunction, and brain health by combining cognitive testing with advanced brain imaging and metabolic analyses. Participants will undergo MRI brain scans to assess brain insulin response, structural changes, and cerebrovascular function. Intranasal insulin will be administered to evaluate cerebral perfusion. Additional tests include advanced MRI techniques for cerebrovascular assessments and functional MRI during glucose ingestion. Blood, urine, and stool samples will be collected for biomarker and multi-omics analyses to characterize BIR. During the study, participants will complete a comprehensive battery of cognitive tests covering memory, executive function, attention, and processing speed. Researchers will collect clinical data about diabetes duration and severity. They will measure brain insulin response and cerebrovascular reactivity and correlate these with cognitive performance. The study includes safety monitoring and will last until 2032, with baseline assessments performed once per participant.
CONDITIONS
Brief Title
Disentangling the Effect of Brain Insulin Resistance on Brain Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 50 and 80 years
- Diagnosis of type 1 diabetes or type 2 diabetes for diabetes participants
- Diabetes duration of at least 10 years for type 1 diabetes
- Diabetes duration of at least 5 years for type 2 diabetes
You will not qualify if you...
- HbA1c greater than 100 mmol/mol
- Diagnosis of diabetes other than 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 study compliance or pose safety risks
- Inability to perform neuropsychological tests due to severe vision, hearing impairment, or language barriers
- Severe claustrophobia
- Metal implants preventing brain MRI scans
- Participants who do not wish to be informed about MRI incidental findings
- Estimated glomerular filtration rate (eGFR) below 45 within 3 months of study visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo cognitive testing and advanced MRI scanning to assess brain insulin resistance, brain structure, and cerebrovascular function.
1 visit (in-person)
Duration - 1 day
Blood, urine, and stool samples are collected for biomarker development and multi-omics analyses.
1 visit (in-person)
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
Research Team
H
Henrik BW Larsson, Professor
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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