NCT07374705 Disentangling the Effect of Brain Insulin Resistance on Brain Health
| NCT ID | NCT07374705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Henrik Bo Wiberg Larsson |
| Condition | Diabetes Type 2 |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2031-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-01-01 with a primary completion date of 2031-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria (all): * age 50-80 years Inclusion Criteria (diabetes only): * Diagnosis of either type 1 diabetes or type 2 diabetes * Diabetes duration of ≥10 years for individuals with type 1 diabetes and ≥5 years for individuals with type 2 diabetes Exclusion Criteria: * HbA1c \>100 mmol/mol * Other type of diabetes * Weight \>140 Kg * Treatment with drugs that cannot be paused for 12 hours * Diagnosis of dementia * Active and recent (1year) malignant disease * History of major stroke * Major depression and/or treatment with antipsychotics * History of traumatic brain injury * Other medical condition or disorder (e.g., epilepsy, recent concussion) that in the opinion of the investigator precludes compliance with the protocol, evaluation of the results or represent an unacceptable risk for the participant's safety. * Inability to perform neuropsychological tests (e.g., severe vision and hearing impairment that cannot be improved with aids such as glasses and hearing aids, or language barrier.) * Severe claustrophobia * Foreign bodies of metal in the body which prohibits brain MRI scans (e.g. pacemaker or screws/plates from surgery in the head or neck region) * Participants who do not wish to be informed about accidental findings by MRI * eGFR measurement \<45 within 3 months of study visit
Contact & Investigator
Henrik BW Larsson, Professor
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT07374705 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Diabetes Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07374705 currently recruiting?
Yes, NCT07374705 is actively recruiting participants. Contact the research team at henrik.bo.wiberg.larsson@regionh.dk for enrollment information.
Where is the NCT07374705 trial being conducted?
This trial is being conducted at Glostrup Municipality, Denmark, Herlev, Denmark, Ulm, Germany.
Who is sponsoring the NCT07374705 clinical trial?
NCT07374705 is sponsored by Henrik Bo Wiberg Larsson. The principal investigator is Henrik BW Larsson, Professor at Rigshospitalet, Denmark. The trial plans to enroll 150 participants.
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