Diabetes nerve damage may signal brain decline, study hints
NCT ID NCT06857994
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study from Denmark looked at 101 people to see if nerve damage from type 2 diabetes is linked to memory and thinking problems. Researchers compared people with and without diabetes using tests of thinking skills, nerve function, and brain scans. The goal was to understand if diabetic neuropathy raises the risk of cognitive decline.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If the study finds a clear link, it could lead to earlier screening for cognitive issues in people with diabetic neuropathy.
- What could go wrong
- This is an observational study, so it cannot prove cause and effect. The results may not apply to younger people or those with different health profiles.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
101 people
The number who actually took part.
- Started
-
Mar 2025
- Finished
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Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Individuals with type 2 diabetes will be recruited among the participants in a former study at teno Diabetes Center Copenhagen, Denmark (DANES-study) who at the time of participation accepted to be contacted again regarding other research projects. Healthy controls will be recruited among persons who have previously participated in studies at SDCC and at the time of participation accepted to be contacted again regarding other research projects. In addition to this, participants will be sought by physical advertisements in the local area, through Facebook groups (all posts that are part of the campaigns, will be created, so it is not possible to comment or tag on them) and through forskningnu.dk.
- Ages
-
65 years and older
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Since the study includes both individuals with and without diabetes, there are two sets of inclusion criteria. Exclusion criteria apply to both indivdiuals with and without diabetes. Inclusion Criteria: For individuals with type 2 diabetes: * Age \>= 65 years * Type 2 Diabetes diagnosis (defined according to the criteria from World Health Organization) for more than 5 years * BMI \<= 35 * Stable diabetes treatment for at least 8 weeks (adjustments of already prescribed insulin doses are accepted) * Plasma hemoglobin ≥ 8.00 mmol/L (male) or ≥ 6.4 mmol/L (female) * Speaks and understands Danish (required for the cognitive tests) * Informed and written consent For individuals without type 2 diabetes: * Age ≥ 65 years * Not diagnosed with T2D diagnosis (defined according to criteria from World Health Organization (WHO)) * Speaks and understands Danish (required for the cognitive tests) * Informed and written consent Exclusion Criteria (all individuals): * Any medical condition which, based on investigators assessment, challenges or hinders participation in cognitive screening, impedes compliance with the study protocol or evaluation of results, including but not limited to psychiatric disorders, neurological disorders, chronic pain disorders etc. * Significant history of alcoholism or drug/chemical substance abuse as per the investigator's judgement. * Individuals in active laser treatment for retinopathy, atrial fibrillation, atrial flutter, or pacemakers since these cannot take part in CAN measurements. * Individuals unable to take part in the MRI because of e.g., metallic objects in the body or severe claustrophobia. * Individuals who do not wish to be informed about accidental findings by MR. * Diagnosis of dementia (ICD F00-F03) or participants who have previously been referred to a dementia clinic. * Severe hypoglycemic events during the past 6 months requiring medical assistance. * Severe renal insufficiency as eGFR ≤ 30 ml/min/1.73 m2 * Inadequately treated blood pressure at screening defined as repeated resting blood pressure outside the range of 90-150 mmHg for systolic and 50-100 for diastolic. * Active or recent (≤ 12 months) malignant disease as judged by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Steno Diabetes Center Copenhagen
Herlev, 2730, Denmark
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