Disentangling the effect of brain insulin resistance on brain health (BIR-BrainHealth): Rationale and study protocol.
Sabrina Wangler, Peter Sørensen, Konni Kass...
https://pubmed.ncbi.nlm.nih.gov/42394131/Actively Recruiting
Led by Henrik Bo Wiberg Larsson · Updated on 2026-02-25
150
Participants Needed
3
Research Sites
13 weeks
Total Duration
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
Disentangling the Effect of Brain Insulin Resistance on Brain Health
H
Henrik BW Larsson, Professor
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Henrik Bo Wiberg Larsson
Lead Sponsor
Steno Diabetes Center Copenhagen
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
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)
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Sabrina Wangler, Peter Sørensen, Konni Kass...
https://pubmed.ncbi.nlm.nih.gov/42394131/Henrik Bo Wiberg Larsson
Lead Sponsor
Steno Diabetes Center Copenhagen
Collaborating Sponsor