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Diabetes nerve damage may signal brain decline, study hints

NCT ID NCT06857994

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.