Brain insulin resistance and brain health in people with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The multicenter project uses cognitive testing, advanced MRI scans, metabolic profiling, and multi-omics to explore whether brain insulin resistance (BIR) and cerebrovascular damage explain cognitive decline in diabetes. This registration covers the MRI components; PET imaging is not included here. The study plans to enroll about 50 people with type 1 diabetes, 50 with type 2 diabetes, and 50 control participants across sites in Denmark and Germany. Participants will be aged 50–80 and meet prespecified diabetes duration and safety criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Rigshospitalet
  Glostrup Municipality, Denmark Recruiting
• Steno Diabetes Center Copenhagen
  Herlev, Denmark Recruiting
• University of Ulm
  Ulm, Germany Recruiting

Study contacts

• Principal investigator: Henrik BW Larsson, Professor — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Henrik BW Larsson, Professor
• Email: henrik.bo.wiberg.larsson@regionh.dk
• Phone: +45 24824294

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.