NCT06857994Completed
The Association Between Cognitive Function and Neuropathy in Individuals With Type 2 Diabetes
The Association Between Cognitive Function and Diabetic Neuropathy in Individuals With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 101 (actual)
- First submitted
- 22 Jan 2025
- Start date
- 10 Mar 2025
- Primary completion date
- 23 Apr 2026
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Diseases
- Type 2 diabetes
- NCT number
- NCT06857994
What you commit to
- Study type: Observational
- Participants enrolled: 101
- From 10 Mar 2025 to the primary completion date, 23 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of dementia (ICD F00-F03) or participants who have previously been referred to a dementia clinic.
Other illness
- 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.
- Active or recent (≤ 12 months) malignant disease as judged by the investigator.
Lab values
- Severe renal insufficiency as eGFR ≤ 30 ml/min/1.73 m2
Other
- 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.
- Severe hypoglycemic events during the past 6 months requiring medical assistance.
- 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.
Who the study is looking for
- 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
Criteria the registry did not label
- 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.
Age in the registry: 65 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.