CompletedNot Applicable

The Association Between Cognitive Function and Neuropathy in Individuals With Type 2 Diabetes

Denmark101 participantsStarted 2025-03-10

Plain-language summary

The goal of this observational study is to evaluate whether individuals with different types of diabetic neuropathy (peripheral and cardiovascular autonomic neuropathy) are at an increased risk of cognitive impairment and to investigate the potential reasons for this association. The primary research question is: Is diabetic peripheral and cariovascular autonomic neuropathy in type 2 diabetes associated with cognitive decline? To address this question, the study will include individuals with and without type 2 diabetes. All participants will undergo comprehensive neuropathy assessments, neuropsychological evaluations and blood biomarker analysis. In addition, some individuals will undergo structural and functional brain MRI.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 cann…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cognitive composite score (global score)

Timeframe: Baseline (only measured once)

Trial details

NCT IDNCT06857994

SponsorSteno Diabetes Center Copenhagen

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04-23

View on ClinicalTrials.gov More Peripheral Diabetic Neuropathy trials